Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer

• Sponsor: Global Isotopes, LLC d/b/a Zevacor Molecular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02260817
• Collaborator: (none)
• Enrollment: 109
• Location: 1
• Arms: 2
• Actual Duration (Months): 44
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

This Phase 3 study will target approximately 100 men over age 18 who have a biochemical relapse or other evidence of relapse of prostate cancer after primary treatment.

The purpose of this study is to:

1. Provide expanded access the drug 11C-choline.

2. Determine the performance characteristics (sensitivity, specificity, positive predictive value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in patients with biochemical relapse of prostate cancer after primary treatment in a prospective manner.

3. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT and PET/MRI positive patients through a prospective study.

4. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using a multivariable analysis of clinical and pathologic data collected prospectively.

5. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline PET/MRI and the combination of 11C-choline PET/CT and PET/MRI

Study Protocol:

1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.

2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.

3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer.

4. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with biopsy or surgical pathology when possible, or by response to treatment on subsequent imaging.

5. Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images.

6. Upon conclusion of each imaging protocol, the referring physician will receive written documentation of the results. At this time, the patient will be considered off study and no further follow up is required.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Prostate Cancer	Drug: 11C-choline Injection	Phase 3

Detailed Description

1. The first arm of this study serves to provide expanded access to 11C-choline injection as currently defined under the reference listed drug label as an investigational drug in geographical service areas where 11C-choline is not available. The second arm expands access as well but also attempts to determine the more effective imaging modality and conditions between PET/CT and PET/MR.

2. The study will consist of patients who have a biochemical relapse or other evidence of relapse after primary treatment. The first arm of the study is open to as many patients who elect to participate in the study that are over the age of 18 and have experienced a biochemical relapse of prostate cancer after primary treatment. The second arm will consist of patients who have been treated with radiation therapy, or androgen suppression and radiation therapy who have a PSA > 2 ng/mL higher than the nadir level. The nadir level in patients who have been treated with androgen suppression and radiation therapy is determined after the serum testosterone level has normalized. This study group will also consist of patients who have been treated with radical prostatectomy and who have a biochemical relapse defined as a PSA of 0.2 ng/mL confirmed at that level or higher on a subsequent PSA test 3 months later. This group may consist of men who have other clinical evidence of relapse such as a suspicious bone scan or CT scan regardless of PSA kinetics. Patients identified as potential subjects will be screened against the eligibility criteria as defined above in Section 5.1.

3. Informed consent will be obtained from all participants before any study related procedures are conducted. Each participant will be informed about the nature of the study, its purpose, and possible risks. Informed consent will be documented by using the written informed consent document approved by the local IRB at the Decatur Memorial Hospital.

4. At the time of referral, patients will be asked to bring their prior records as it pertains to their prostate cancer history. Data collected from outside records, such as radiographic studies, previous imaging studies and biopsies will be incorporated into the study record.

5. Abstracted data for the study record will include:

6. Patient demographics such as age, race, and family history of prostate cancer

7. Risk factors such as finasteride or dutasteride use, and environmental exposure (eg. Agent orange)

8. Prostate exam results, most recent within last 90 days

9. PSA test results, most current and past

10. Past medical and surgical history

11. Current medications

12. Allergies

13. Pathology reports

14. Imaging reports

15. Date of diagnosis

16. Date(s) of biochemical relapse and coordinating PSA results. Once all records have been assessed for eligibility, an order for the 11C-choline PET CT scan and MRI scan will be requested from the referring physician and patient will be scheduled and given the appropriate prep instructions.

17. Both arms of the study will undergo a 11C-choline PET CT scan and MRI scan. The CT scan will be performed with intravenous contrast unless deemed unsafe by lab values. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Unequivocal evidence of metastasis on both conventional imaging and 11C-choline PET will be considered a true positive. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with biopsy or surgical pathology when possible, or by response to treatment on subsequent imaging. If confirmation of metastasis is not achievable by biopsy or surgical pathology, then confirmation will be achieved with 11C-choline PET CT and MRI images obtained 3 months after treatment conclusion. Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images.

18. Upon conclusion of each imaging protocol, the referring physician will receive written documentation of the results. At this time, the patient will be considered off study and no further follow up is required.

Study Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Expanded Access to 11C Choline PET/CT and 11C Choline PET/MR for Staging of Recurrent Prostate Cancer With Comparison Study of CT and MR Modalities
• Actual Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Expanded Access for 11C-Choline The key objective of this study is to provide expanded access to this drug product as currently defined under the reference listed drug as an investigational drug in geographical service areas where 11C-choline injection is not available. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm of the study will not be further analyzed beyond that need for clinical diagnosis.	Drug: 11C-choline Injection; Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images; Other Names: CCH Injection, C11 Choline Injection
Experimental: 11C-Choline Comparison of Modalities 11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images	Drug: 11C-choline Injection; Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images; Other Names: CCH Injection, C11 Choline Injection

Outcome Measures

Primary Outcome Measures

1. Evidence of Metastatic Prostate Cancer [After 11C-choline PET CT scan and MRI scans, approximately 1 day. If surgery or response to treatment required to evaluate, approximately 1 to 3 months.]

   The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. This Outcome is only measured for Arm 2 of this study. True Positive: True positives will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images confirmed with biopsy, surgical pathology, or by response to treatment with androgen suppression or other medical or radiation therapy. True Negative: True negatives will consist of negative images. False Positive: False positive will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images, but without corresponding confirmation from biopsy, surgical pathology or response to treatment. False Negative: False negative will consist of negative images, but with positive biopsy, surgical pathology or a response to treatment.

2. Sensitivity of 11C Choline PET Imaging Scans [Approximately 1 day post-scan for patient results]

   The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging sensitivity. Sensitivity of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Negative). This Outcome is only measured for Arm 2 of this study.

3. Specificity of 11C Choline PET Imaging Scans [Approximately 1 day post-scan for patient results]

   The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging specificity. Specificity of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Positive). This Outcome is only measured and reported for Arm 2.

4. Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans [Approximately 1 day post-scan for patient results]

   The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' positive predictive value. Positive Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Positive). This Outcome is only measured for Arm 2.

5. Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans [Approximately 1 day post-scan for patient results]

   The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' negative predictive value. Negative Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Negative). This Outcome is only measured for Arm 2.

6. Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation [Approximately 1 day post-scan for patient results]

   Comparison of the results of participants' imaging modalities and whether those imaging modalities resulted in confirmation of Prostate Cancer (PCa). This Outcome is only measured for Arm 2.

Secondary Outcome Measures

1. Median Age at Primary Treatment [The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study)]

   The median age at primary treatment for Arm 2 participants.

2. Median PSA at Diagnosis of Arm 2 Participants [The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study)]

   The Prostate-Specific Antigen (PSA) measurement of participants at their original prostate cancer diagnosis was collected at entry to this trial. It is reported as nanograms of PSA per milliliter (ng/mL) of blood. The Median of all reported PSAs is reported here.

3. Clinical T (cT) Stage of Arm 2 Participants [The participants' clinical stage data was collected upon study enrollment (approximately 1 week into study)]

   An accounting of the approximate clinical (pre-treatment) stage for the Arm 2 participants. Clinical staging is based on the results of tests done before surgery. T1: PC is too small to be seen on a scan or felt during prostate examination T1a: PC is in < 5% of removed tissue T1b: PC is in > 5% or more of removed tissue T1c: PC is found by biopsy T2: PC is completely inside prostate T2a: PC is in only half of one side of prostate T2b: PC is in more than half of one side of prostate, but not both sides T2c: PC is in both sides but is still inside prostate T3: PC has broken through the capsule of prostate T3a: PC has broken through the capsule of prostate T3b: PC has spread into seminal vesicles T4: PC has spread into other nearby body organs

4. Median Primary Biopsy Gleason Score of Arm 2 Participants [The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study)]

   The median primary Biopsy Gleason Score for the Arm 2 participants' will be reported. The Gleason Score is the grading system used to determine the aggressiveness of prostate cancer. Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. Gleason scores 2-4 are typically found in smaller tumors located in the transitional zone (around the urethra). The majority of treatable/treated cancers are of Gleason scores 5 - 7 and are detected due to biopsy after abnormal digital rectal exam or prostate specific antigen evaluation. The cancer is typically located in the peripheral zone usually the posterior portion. Tumors with Gleason scores 8-10 tend to be advanced neoplasms that are unlikely to be cured.

5. Primary Treatment Modality of Arm 2 Participants [The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study)]

   An accounting of the primary treatment modalities undergone by the participants in Arm 2 prior to their involvement in the trial will be reported. Modalities reported below are: Androgen Deprivation Therapy (ADT) External Beam Radiation Therapy (EBRT) Brachytherapy Cryoablation Cystoprostatectomy Intensity-Modulated Radiation Therapy (IMRT) Radical Prostatectomy (RP)

6. Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants [The participants' primary pathological staging data was collected upon study enrollment (approximately 1 week into study)]

   The pathological stage of PC at primary diagnosis for Arm 2 participants was collected. pT is based on how different from normal the cells in samples of tissue recovered from surgery look under a microscope. T1: PC is too small to be seen on a scan or felt during prostate examination T1a: PC is in < 5% of removed tissue T1b: PC is in > 5% or more of removed tissue T1c: PC is found by biopsy T2: PC is completely inside prostate T2a: PC is in only half of one side of prostate T2b: PC is in more than half of one side of prostate, but not both sides T2c: PC is in both sides but is still inside prostate T3: PC has broken through the capsule of prostate T3a: PC has broken through the capsule of prostate T3b: PC has spread into seminal vesicles T4: PC has spread into other nearby body organs

7. Primary Surgical Margins of Arm 2 Participants [The participants' primary surgical margins data was collected upon study enrollment (approximately 1 week into study)]

   A census of the primary surgical margins of participants in Arm 2 will reported. The surgical margins are the set of surfaces that were cut by the surgeon in order to remove the specimen from the body. Positive Margin: surgical margins with disease present. Negative Margin: surgical margins with no disease present.

8. Primary Positive Lymph Node Ratio of Arm 2 Participants [The participants' primary positive lymph note ratio was collected upon study enrollment (approximately 1 week into study)]

   A census of the positive lymph node ratio, defined as ratio of positive lymph nodes to all lymph nodes removed, for the participants of Arm 2 will be reported. The N refers to the the number of nearby lymph nodes that have cancer. NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer.

9. Additional Treatment and Type for Arm 2 Participants [The participants' additional primary treatment data was collected upon study enrollment (approximately 1 week into study)]

   A census of the additional treatments undergone by participants prior to enrollment in the study, if undergone, for the participants of Arm 2 will be reported. None Androgen Deprivation Therapy (ADT) Radiation Therapy (RT) Electron Beam Radiation Therapy (EBRT) Lycopene (herbal treatment) Salvage Radiation Therapy (RT) Salvage Radical Prostatectomy (RP) Adjuvant Radiation Therapy (RT) Bilateral Pelvis Lymph Node Dissection

10. Median Months to Biochemical Relapse of Arm 2 Participants [The participants' biochemical relapse data was collected upon study enrollment (approximately 1 week into study)]

    The median of the Arm 2 participants' data between initial treatment and biochemical relapse, occurring prior to study enrollment, measured in months, will be reported.

11. Median Age of Arm 2 Participant at PET Imaging [The participants' age at study entry was collected upon study enrollment (approximately 1 week into study)]

    The median age (at time of study) of participants of Arm 2 will be reported in years.

12. Median PSA of Arm 2 Participant at PET Imaging [The participants' PSA was collected upon study enrollment (approximately 1 week into study)]

    The median of the PSA of Arm 2 participants at study entry will be reported as nanograms of PSA per milliliter (ng/mL) of blood

13. Median PSA Doubling Time of Arm 2 Participants at PET Imaging [The participants' PSA doubling time was collected upon study enrollment (approximately 1 week into study)]

    The median of the time, measured in months that an Arm 2 participant's PSA has doubled from initial diagnosis to PSA measured at study enrollment.

14. Median PSA Velocity of Arm 2 Participants at PET Imaging [The participants' PSA velocity was collected upon study enrollment (approximately 1 week into study)]

    The median PSA velocity (measured in ng/mL/month) of the Arm 2 participants will be reported.

15. ADT (Androgen Deprivation Therapy) in Participant at PET Imaging [The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study)]

    An accounting of whether the participants of Arm 2 have undergone androgen deprivation therapy (ADT).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. For biochemical relapse after primary treatment

2. PSA > 0.2 ng/ml after radical prostatectomy confirmed at that level or higher on a subsequent test 3 months later

3. PSA increase >2 ng/ml from nadir following radiation therapy

4. PSA increase >2 ng/ml from nadir following radiation therapy plus androgen deprivation therapy with nadir defined with normalized testosterone level

5. Two consecutive PSA increases from nadir level after androgen blockade or androgen suppression therapy

6. Kidney function with GFR > 60 mL/sec/1.73m2 and Creatinine < 1.7mg, collected within 90 days of planned scan

7. if GFR is > or equal to 60 mL/sec/1.73m2, PET/CT will be completed with contrast

8. if GFR is < 60 mL/sec/1.73m2, PET/CT will be completed without contrast

9. if Creatinine is > than 1.7 mg, Radiology will follow ACR recommendations as outlined in department policy.

10. No known allergy to iodinated radiologic contrast media

11. Able to have MRI based on screening evaluation. If patient is found to be MRI incompatible, the 11C-choline PET/MRI portion of the study will not be completed. Please see the provided contact numbers for further options.

12. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Exclusion Criteria:

1. ECOG Performance Status > 2.

2. Concurrent malignancy, i.e. colon cancer.

3. Treatment for another malignancy except superficial skin cancer within 5 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Decatur Memorial Hospital	Decatur	Illinois	United States	62526

Sponsors and Collaborators

• Global Isotopes, LLC d/b/a Zevacor Molecular

Investigators

• Principal Investigator: Thomas H Tarter, M.D, Ph.D, Decatur Memorial Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 30, 2015

More Information

Publications

None provided.

• Responsible Party: Global Isotopes, LLC d/b/a Zevacor Molecular
• ClinicalTrials.gov Identifier: NCT02260817
• Other Study ID Numbers: ZM-CCH-40-PTL0114
• First Posted: Oct 9, 2014
• Last Update Posted: Dec 17, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by Global Isotopes, LLC d/b/a Zevacor Molecular: Prostate Cancer; 11C Choline; PET Imaging
• Additional relevant MeSH terms: Prostatic Neoplasms; Choline

Study Results

Participant Flow

Recruitment Details	Recruitment dates: 10/14 - 6/16, dosage and imaging only at Decatur Memorial Hospital in Decatur, IL.
Pre-assignment Detail	No enrolled participants were excluded from either arm of the study prior to assignment.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Period Title: Overall Study
STARTED	14	95
COMPLETED	14	58
NOT COMPLETED	0	37

Baseline Characteristics

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities	Total
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images	Total of all reporting groups
Overall Participants	14	95	109
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 28.6%	59 62.1%	63 57.8%
>=65 years	10 71.4%	36 37.9%	46 42.2%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	14 100%	95 100%	109 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	14 100%	95 100%	109 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	2 2.1%	2 1.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 7.1%	7 7.4%	8 7.3%
White	13 92.9%	86 90.5%	99 90.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	14 100%	95 100%	109 100%

Outcome Measures

1. Primary Outcome

Title	Evidence of Metastatic Prostate Cancer
Description	The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. This Outcome is only measured for Arm 2 of this study. True Positive: True positives will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images confirmed with biopsy, surgical pathology, or by response to treatment with androgen suppression or other medical or radiation therapy. True Negative: True negatives will consist of negative images. False Positive: False positive will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images, but without corresponding confirmation from biopsy, surgical pathology or response to treatment. False Negative: False negative will consist of negative images, but with positive biopsy, surgical pathology or a response to treatment.
Time Frame	After 11C-choline PET CT scan and MRI scans, approximately 1 day. If surgery or response to treatment required to evaluate, approximately 1 to 3 months.

Outcome Measure Data

Analysis Population Description

Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	58
True Positive	0 0%	36 37.9%
True Negative	0 0%	10 10.5%
False Positive	0 0%	11 11.6%
False Negative	0 0%	1 1.1%

2. Primary Outcome

Title	Sensitivity of 11C Choline PET Imaging Scans
Description	The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging sensitivity. Sensitivity of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Negative). This Outcome is only measured for Arm 2 of this study.
Time Frame	Approximately 1 day post-scan for patient results

Outcome Measure Data

Analysis Population Description

Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	58
Number [% of correctly identified positives]	97.29

3. Primary Outcome

Title	Specificity of 11C Choline PET Imaging Scans
Description	The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging specificity. Specificity of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Positive). This Outcome is only measured and reported for Arm 2.
Time Frame	Approximately 1 day post-scan for patient results

Outcome Measure Data

Analysis Population Description

Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	58
Number [% correctly identified negatives]	47.61

4. Primary Outcome

Title	Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans
Description	The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' positive predictive value. Positive Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Positive). This Outcome is only measured for Arm 2.
Time Frame	Approximately 1 day post-scan for patient results

Outcome Measure Data

Analysis Population Description

Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	58
Number [Probability of disease (%)]	76.59

5. Primary Outcome

Title	Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans
Description	The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' negative predictive value. Negative Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Negative). This Outcome is only measured for Arm 2.
Time Frame	Approximately 1 day post-scan for patient results

Outcome Measure Data

Analysis Population Description

Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	58
Number [Probability of being disease-free (%)]	90.90

6. Primary Outcome

Title	Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation
Description	Comparison of the results of participants' imaging modalities and whether those imaging modalities resulted in confirmation of Prostate Cancer (PCa). This Outcome is only measured for Arm 2.
Time Frame	Approximately 1 day post-scan for patient results

Outcome Measure Data

Analysis Population Description

This population only includes those Arm 2 participants with positive PET imaging.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	36
Positive PET, Negative CT, Negative MRI	11 78.6%
Positive PET, Positive CT, Negative MRI	6 42.9%
Positive PET, Negative CT, Positive MRI	11 78.6%
Positive PET, Positive CT, Positive MRI	8 57.1%

7. Secondary Outcome

Title	Median Age at Primary Treatment
Description	The median age at primary treatment for Arm 2 participants.
Time Frame	The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only Arm 2 participants' data was collected.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	58
Median (Full Range) [years]	63

8. Secondary Outcome

Title	Median PSA at Diagnosis of Arm 2 Participants
Description	The Prostate-Specific Antigen (PSA) measurement of participants at their original prostate cancer diagnosis was collected at entry to this trial. It is reported as nanograms of PSA per milliliter (ng/mL) of blood. The Median of all reported PSAs is reported here.
Time Frame	The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only Arm 2 participants' data was collected. *Note: 4 participants' PSA was not reported.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	54
Median (Full Range) [ng/ml]	13.07

9. Secondary Outcome

Title	Clinical T (cT) Stage of Arm 2 Participants
Description	An accounting of the approximate clinical (pre-treatment) stage for the Arm 2 participants. Clinical staging is based on the results of tests done before surgery. T1: PC is too small to be seen on a scan or felt during prostate examination T1a: PC is in < 5% of removed tissue T1b: PC is in > 5% or more of removed tissue T1c: PC is found by biopsy T2: PC is completely inside prostate T2a: PC is in only half of one side of prostate T2b: PC is in more than half of one side of prostate, but not both sides T2c: PC is in both sides but is still inside prostate T3: PC has broken through the capsule of prostate T3a: PC has broken through the capsule of prostate T3b: PC has spread into seminal vesicles T4: PC has spread into other nearby body organs
Time Frame	The participants' clinical stage data was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only data from Arm 2 participants' was collected. Note: Clinical Staging for 4 participants was not reported.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	54
cT Stage: T1c	0 0%	34 35.8%
cT Stage: T2	0 0%	20 21.1%

10. Secondary Outcome

Title	Median Primary Biopsy Gleason Score of Arm 2 Participants
Description	The median primary Biopsy Gleason Score for the Arm 2 participants' will be reported. The Gleason Score is the grading system used to determine the aggressiveness of prostate cancer. Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. Gleason scores 2-4 are typically found in smaller tumors located in the transitional zone (around the urethra). The majority of treatable/treated cancers are of Gleason scores 5 - 7 and are detected due to biopsy after abnormal digital rectal exam or prostate specific antigen evaluation. The cancer is typically located in the peripheral zone usually the posterior portion. Tumors with Gleason scores 8-10 tend to be advanced neoplasms that are unlikely to be cured.
Time Frame	The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only data collected from Arm 2 Participants. Note: Biopsy Gleason Grade was not reported for 1 participant.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	57
Median (Full Range) [units on a scale]	7

11. Secondary Outcome

Title	Primary Treatment Modality of Arm 2 Participants
Description	An accounting of the primary treatment modalities undergone by the participants in Arm 2 prior to their involvement in the trial will be reported. Modalities reported below are: Androgen Deprivation Therapy (ADT) External Beam Radiation Therapy (EBRT) Brachytherapy Cryoablation Cystoprostatectomy Intensity-Modulated Radiation Therapy (IMRT) Radical Prostatectomy (RP)
Time Frame	The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only data collected from Arm 2 Participants.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	58
ADT	1 7.1%
ADT + Brachytherapy	1 7.1%
ADT + EBRT + Brachytherapy	2 14.3%
Brachytherapy	4 28.6%
Brachytherapy + EBRT	1 7.1%
Cystoprostratectomy	1 7.1%
EBRT	10 71.4%
EBRT + ADT	3 21.4%
IMRT	1 7.1%
RP	34 242.9%

12. Secondary Outcome

Title	Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants
Description	The pathological stage of PC at primary diagnosis for Arm 2 participants was collected. pT is based on how different from normal the cells in samples of tissue recovered from surgery look under a microscope. T1: PC is too small to be seen on a scan or felt during prostate examination T1a: PC is in < 5% of removed tissue T1b: PC is in > 5% or more of removed tissue T1c: PC is found by biopsy T2: PC is completely inside prostate T2a: PC is in only half of one side of prostate T2b: PC is in more than half of one side of prostate, but not both sides T2c: PC is in both sides but is still inside prostate T3: PC has broken through the capsule of prostate T3a: PC has broken through the capsule of prostate T3b: PC has spread into seminal vesicles T4: PC has spread into other nearby body organs
Time Frame	The participants' primary pathological staging data was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only data collected from Arm 2 participants. Note: Pathological Stage data not collected for 26 patients.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	32
pT2a	1 7.1%
pT2c	14 100%
pT3a	9 64.3%
pT3b	8 57.1%

13. Secondary Outcome

Title	Primary Surgical Margins of Arm 2 Participants
Description	A census of the primary surgical margins of participants in Arm 2 will reported. The surgical margins are the set of surfaces that were cut by the surgeon in order to remove the specimen from the body. Positive Margin: surgical margins with disease present. Negative Margin: surgical margins with no disease present.
Time Frame	The participants' primary surgical margins data was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only data for Arm 2 participants was collected. Note: Primary Surgical Margins were not collected for 26 participants.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	32
Negative Surgical Margins	13 92.9%
Positive Surgical Margins	19 135.7%

14. Secondary Outcome

Title	Primary Positive Lymph Node Ratio of Arm 2 Participants
Description	A census of the positive lymph node ratio, defined as ratio of positive lymph nodes to all lymph nodes removed, for the participants of Arm 2 will be reported. The N refers to the the number of nearby lymph nodes that have cancer. NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer.
Time Frame	The participants' primary positive lymph note ratio was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only data collected from Arm 2 participants. Note: Primary Positive Lymph Node Ratio was not collected for 26 participants.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	32
NX	3 21.4%
N0	25 178.6%
N1	4 28.6%

15. Secondary Outcome

Title	Additional Treatment and Type for Arm 2 Participants
Description	A census of the additional treatments undergone by participants prior to enrollment in the study, if undergone, for the participants of Arm 2 will be reported. None Androgen Deprivation Therapy (ADT) Radiation Therapy (RT) Electron Beam Radiation Therapy (EBRT) Lycopene (herbal treatment) Salvage Radiation Therapy (RT) Salvage Radical Prostatectomy (RP) Adjuvant Radiation Therapy (RT) Bilateral Pelvis Lymph Node Dissection
Time Frame	The participants' additional primary treatment data was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

only data from Arm 2 Participants is collected. Note: Additional Treatment was not reported for 1 participant.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	57
Adjuvant RT	3 21.4%
ADT	11 78.6%
Bilateral Pelvis Lymph Node Dissection	1 7.1%
EBRT	1 7.1%
Lycopene	1 7.1%
None	31 221.4%
Salvage RP	1 7.1%
Salvage RT	5 35.7%
Salvage RT + ADT	3 21.4%

16. Secondary Outcome

Title	Median Months to Biochemical Relapse of Arm 2 Participants
Description	The median of the Arm 2 participants' data between initial treatment and biochemical relapse, occurring prior to study enrollment, measured in months, will be reported.
Time Frame	The participants' biochemical relapse data was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

only data from Arm 2 participants is collected. Note: Biochemical Relapse Data was not collected for 2 participants.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	56
Median (Full Range) [months]	40

17. Secondary Outcome

Title	Median Age of Arm 2 Participant at PET Imaging
Description	The median age (at time of study) of participants of Arm 2 will be reported in years.
Time Frame	The participants' age at study entry was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only data collected from Arm 2 participants is reported.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	58
Median (Full Range) [years]	69

18. Secondary Outcome

Title	Median PSA of Arm 2 Participant at PET Imaging
Description	The median of the PSA of Arm 2 participants at study entry will be reported as nanograms of PSA per milliliter (ng/mL) of blood
Time Frame	The participants' PSA was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

only data collected for Arm 2 participants.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	58
Median (Full Range) [ng/ml of blood]	3.58

19. Secondary Outcome

Title	Median PSA Doubling Time of Arm 2 Participants at PET Imaging
Description	The median of the time, measured in months that an Arm 2 participant's PSA has doubled from initial diagnosis to PSA measured at study enrollment.
Time Frame	The participants' PSA doubling time was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only data collected from Arm 2 participants is reported. Note: PSA doubling time (in months) was not collected for 3 participants.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	55
Median (Full Range) [months]	4.91

20. Secondary Outcome

Title	Median PSA Velocity of Arm 2 Participants at PET Imaging
Description	The median PSA velocity (measured in ng/mL/month) of the Arm 2 participants will be reported.
Time Frame	The participants' PSA velocity was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only data collected from Arm 2 participants is reported. Note: PSA velocity was not collected for 3 participants.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	55
Median (Full Range) [ng/mL/month]	0.09

21. Secondary Outcome

Title	ADT (Androgen Deprivation Therapy) in Participant at PET Imaging
Description	An accounting of whether the participants of Arm 2 have undergone androgen deprivation therapy (ADT).
Time Frame	The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study)

Outcome Measure Data

Analysis Population Description

Only the Arm 2 participants data is reported. Note: ADT information was not collected for 2 participants.

Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer	11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.	11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
Measure Participants	0	56
No ADT received	48 342.9%
ADT received	8 57.1%

Adverse Events

Time Frame	Participants were monitored throughout the imaging process during the administration of the imaging agents and immediately thereafter. They were contacted within 1 day after the scan for assessment.
Adverse Event Reporting Description	Adverse Events were assessed per the standard Adverse Events definition. Patients were contacted by telephone 24 hours post-C11 Choline PET scan for any follow-up concerns and were also told to report any immediate or additional concerns.
Arm/Group Title	11C-choline for Staging of Recurrent Prostate Cancer		11C-choline Comparison Study of CT and MR Modalities
Arm/Group Description	The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm will not be further analyzed beyond that need for clinical diagnosis.		11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions. Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol: 15 - millicuries (mCi) 11C-choline IV Injection PET images skull base to mid thigh with 3 min per bed position Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol Fusion of PET and CT images 2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol: No IV contrast High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs Fusion of coronal and PET images
All Cause Mortality
	11C-choline for Staging of Recurrent Prostate Cancer		11C-choline Comparison Study of CT and MR Modalities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/95 (0%)
Serious Adverse Events
	11C-choline for Staging of Recurrent Prostate Cancer		11C-choline Comparison Study of CT and MR Modalities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/95 (0%)
Other (Not Including Serious) Adverse Events
	11C-choline for Staging of Recurrent Prostate Cancer		11C-choline Comparison Study of CT and MR Modalities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/95 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.