18F-DCFBC PET/CT in Prostate Cancer

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT02190279
• Collaborator: (none)
• Enrollment: 116
• Location: 1
• Arms: 3
• Actual Duration (Months): 42
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

Background:

• Prostate cancer is the second leading cause of cancer deaths in American men. A chemical called a radiotracer helps doctors get images of this type of cancer. Researchers want to test a radiotracer called N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC).

Objective:

• To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body.

Eligibility:

• Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have relapsed, or has spread outside the prostate.

Design:

• Participants will be screened with physical exam and medical history. They will give a blood sample.

• Participants will be divided into three groups.

Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or biopsy at National Institutes of Health (NIH).

Group 2: people who had their prostate removed or had radiation therapy and now have a rising prostate-specific antigen (PSA) without other signs of disease.

Group 3: people whose cancer has spread to other areas of the body.

• Participants will have 18F-DCFBC injected into a vein then imaged in a positron emission tomography (PET)/computed tomography (CT) camera. During the scans, they will lie on their back on the scanner table.

• Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a contrast agent injected through an intravenous line.

• Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21 days of the 18F-DCFBC scan to look for prostate cancer in the bone.

• Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans.

• A few days after each scan, participants will be contacted for follow-up.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms; Prostate Cancer	Drug: 18F DCFBC; Drug: Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT)	Early Phase 1

Detailed Description

Background

• Prostate cancer is the second leading cause of cancer deaths in American men.

• Current methods of imaging advanced prostate cancer (computed tomography ((CT) and bone scan) are non specific and new, more specific molecular imaging probes are sought.

• Many prostate cancers express the prostate specific membrane antigen (PSMA) a transmembrane protein with N-acetylated alpha-linked acidic dipeptidase (NAALADase) enzymatic activity. PSMA is also expressed in angiogenesis but otherwise has limited expression in normal tissue.

• N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC) is a radiolabeled positron emission tomography (PET) agent which binds with high affinity to PSMA and through whole-body non-invasive functional imaging, may provide new information on the expression of PSMA.

Primary Objective

• To assess the ability of 18F-DCFBC to differentiate between tumorous and nontumorous tissues in localized, recurrent (based on rising prostatic-specific antigen ((PSA) post treatment) and metastatic prostate cancer

Eligibility

• Subject is greater than or equal to 18 years old

• Eastern Cooperative Oncology Group (ECOG) 0-2 with adenocarcinoma of the prostate and fits criteria for one of the following:

• ARM 1

-- Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

---A multiparametric magnetic resonance imaging (MRI) (standard of care at the National Institutes of Health ((NIH) Clinical Center) must be performed within 4 months of18F-DCFBC injection with findings suggestive for prostate cancer and confirmed with histopathology.

• ARM 2

• Patients with biochemical prostate cancer relapse after definitive treatment

• For patients status post radiation therapy for prostate cancer, a PSA increase from post radiation therapy nadir

• OR

• For patients status post prostatectomy, any PSA >/=0.2 ng/ml

• Nonspecific or no evidence for disease on standard imaging modality

• ARM 3

• Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to 18F-DCFBC imaging.

Design

This is a single site 3-arm study enrolling a total of 110 evaluable patients: Arm 1 will include 12 patients with presumed localized prostate cancer scheduled to undergo prostatectomy or biopsy within 4 months of enrollment; Arm 2 will include 78 patients with biochemical recurrence without evidence of metastasis on conventional imaging; and Arm 3 will include 20 patients with known metastatic disease who may or may not be on or/scheduled to begin therapeutic intervention. Patients with presumed localized disease will undergo a standard of care, clinical multiparametric endorectal coil MRI in the National Cancer Institute (NCI) Molecular Imaging Clinic within 4 months of screening. Patients in Arm 3 will undergo 2 imaging sessions: baseline and 4-6 month follow-up. Clinical records (including PSA) and treatment (if any) that occurred in the imaging interval must be available. All patients in Arm 3 will also undergo Na18F PET/CT for evaluation of bone metastases as part of this protocol. In order to allow for a small number of nonevaluable patients, the accrual ceiling will be set at 125.

Study Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Pilot Study of 18F-DCFBC PET/CT in Prostate Cancer
• Actual Study Start Date: Jul 12, 2014
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Jan 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Suspected Localized Prostate Cancer Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.	Drug: 18F DCFBC; Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Experimental: Biochemical Recurrence Patients with biochemical prostate cancer relapse after definitive treatment	Drug: 18F DCFBC; Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Experimental: Known Metastatic Disease Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.	Drug: 18F DCFBC; Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.; Drug: Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT); Other Names: Na 18F PET/CT

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Local Recurrence, Lymph Node Metastases or Distant Metastatic Sites Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Imaging [1 hour and 2 hour timepoints at baseline]

   Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites.

2. Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) [1 hour and 2 hour timepoints at baseline]

   Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered a positive lesion for prostate cancer.The measure would be compared with other imaging or pathology.

Secondary Outcome Measures

1. Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) [Date treatment consent signed to date off study, approximately 42 months and 21 days]

   Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

2. Number of Detectable Lesions in Bone With Respect to 18F-DCFBC Imaging and/or Na18F Positron Emission Tomography (PET)/Computed Tomography (CT) in Patients With Known Metastatic Disease [3 months]

   18F-DFBC and conventional imaging was used to identify positive lesions in bone.

3. Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH) [1 hour and 2 hour post injection (p.i.)]

   Primary prostate cancer was compared to BPH nodules and normal prostate tissue using a one-way analysis of variance (Anova). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or blood pool for lymph nodes.

4. Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy [1 month]

   Tissue was obtained and stained with hematoxylin-eosin. The resulting whole mount specimens were correlated with MRI and PET/CT imaging. For each dominant/index tumor (largest tumor with highest Gleason score) was determined.

5. Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland [3 months]

   Visualizing positive lesions with DCFBC and mpMRI.

6. Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group [3 months]

   Visualizing positive lesions as a function of PSA value. Undetectable PSA is normal in this population.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

• INCLUSION CRITERIA:

• Subject is greater than or equal to18 years old

• Platelet count > 50,000/mm^3

• Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.

• Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.

• Categories

• ARM 1 only

---For patients with presumed localized disease (any tumor (T), nodes 0 (N0), metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI) (standard of care at the National Institutes of Health ((NIH) Clinical Center) must be performed within 4 months of the N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer and a prostate lesion at least 6mm or greater. Must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging.

• ARM 2 only:

• For patients status post radiation therapy for prostate cancer, any prostatic-specific antigen (PSA) increase from post radiation therapy nadir

• OR

• For patients status post prostatectomy, a PSA >/=0.2 ng/ml

• Nonspecific or no evidence for disease on standard imaging modality

• ARM 3 only:

• Patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality. If only soft tissue metastasis, one lesion must measure at least 6mm or greater. Patients must have confirmation of prostate cancer prior to 18FDCFBC imaging

Note: A patient who is eligible for one arm, subsequently may cross-over into a different arm.

EXCLUSION CRITERIA:

• Subjects for whom participating would significantly delay the scheduled standard of care therapy

• Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.

• Subjects with severe claustrophobia unresponsive to oral anxiolytics

• Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.

• Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry

• Serum creatinine > 2 times the upper limit of normal

• Total bilirubin > 2 times the upper limit of normal

• Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) greater than 3 times the upper limit of normal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Maria Liza Lindenberg, M.D., National Cancer Institute (NCI)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 27, 2015
• Informed Consent Form - Dec 14, 2015

More Information

Additional Information:

• NIH Clinical Center Detailed Web Page

Publications

None provided.

• Responsible Party: Maria Liza Lindenberg, M.D., Principal Investigator, National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT02190279
• Other Study ID Numbers: 140140; 14-C-0140
• First Posted: Jul 15, 2014
• Last Update Posted: Apr 23, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maria Liza Lindenberg, M.D., Principal Investigator, National Cancer Institute (NCI): Prostate Specific Membrane Antigen; Radiolabeled PET Agent; Imaging; NaF
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Suspected Localized Prostate Cancer	Biochemical Recurrence	Known Metastatic Disease
Arm/Group Description	Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater. N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Patients with biochemical prostate cancer relapse after definitive treatment 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging. 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Period Title: Overall Study
STARTED	16	69	31
COMPLETED	13	69	28
NOT COMPLETED	3	0	3

Baseline Characteristics

Arm/Group Title	Suspected Localized Prostate Cancer	Biochemical Recurrence	Known Metastatic Disease	Total
Arm/Group Description	Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater. N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Patients with biochemical prostate cancer relapse after definitive treatment 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging. 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Total of all reporting groups
Overall Participants	16	69	31	116
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	6 37.5%	34 49.3%	14 45.2%	54 46.6%
>=65 years	10 62.5%	35 50.7%	17 54.8%	62 53.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.58 (8.53)	65.33 (6.67)	63.93 (11.41)	64.85 (8.38)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	16 100%	69 100%	31 100%	116 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	16 100%	69 100%	31 100%	116 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	3 4.3%	1 3.2%	4 3.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	4 25%	7 10.1%	3 9.7%	14 12.1%
White	12 75%	59 85.5%	27 87.1%	98 84.5%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	16 100%	69 100%	31 100%	116 100%
Gleason Grade at Diagnosis (Count of Participants)
Gleason Grade 5	1 6.3%	1 1.4%	0 0%	2 1.7%
Gleason Grade 6	3 18.8%	7 10.1%	7 22.6%	17 14.7%
Gleason Grade 7-8	9 56.3%	48 69.6%	11 35.5%	68 58.6%
Gleason Grade 9-10	3 18.8%	12 17.4%	9 29%	24 20.7%
Not available	0 0%	1 1.4%	1 3.2%	2 1.7%
Prior Prostate Cancer Therapy (Count of Participants)
None	15 93.8%	0 0%	4 12.9%	19 16.4%
Radical Prostatectomy	0 0%	49 71%	1 3.2%	50 43.1%
Brachytherapy/Radiation	1 6.3%	8 11.6%	2 6.5%	11 9.5%
ADT + Surgery or Radiation	0 0%	2 2.9%	5 16.1%	7 6%
ADT + Chemotherapy	0 0%	0 0%	7 22.6%	7 6%
ADT	0 0%	0 0%	1 3.2%	1 0.9%
Combo radical prostectomy and radiation therapy	0 0%	9 13%	8 25.8%	17 14.7%
Unknown	0 0%	1 1.4%	0 0%	1 0.9%
Baseline Imaging (Count of Participants)
NaF PET/CT	13 81.3%	0 0%	28 90.3%	41 35.3%
DCFBC(1h) PET/CT	13 81.3%	68 98.6%	28 90.3%	109 94%
DCFBC(2h) PET/CT	13 81.3%	68 98.6%	27 87.1%	108 93.1%
Prostatic-Specific Antigen (PSA) at Baseline (ng/ml) [Median (Full Range) ]
Median (Full Range) [ng/ml]	37.5	1.63	1.90	13.67
Castration Status (Count of Participants)
Untreated	0 0%	0 0%	3 9.7%	3 2.6%
Castrate-sensitive	0 0%	0 0%	14 45.2%	14 12.1%
Castrate-resistant	0 0%	0 0%	11 35.5%	11 9.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Local Recurrence, Lymph Node Metastases or Distant Metastatic Sites Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Imaging
Description	Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites.
Time Frame	1 hour and 2 hour timepoints at baseline

Outcome Measure Data

Analysis Population Description

In Arm 1: 3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue. Arm 2: 1 patient had technical issues and was not included in the final analysis Arm 3: 2 patients were not imaged and 1 patient withdrew consent

Arm/Group Title	Suspected Localized Prostate Cancer	Biochemical Recurrence	Known Metastatic Disease
Arm/Group Description	Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater. N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Patients with biochemical prostate cancer relapse after definitive treatment 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging. 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Measure Participants	13	68	28
Lymph nodes	1 6.3%	39 56.5%	28 90.3%
Distant sites	0 0%	10 14.5%	10 32.3%
Prostate bed/anastomosis	8 50%	30 43.5%	28 90.3%

2. Primary Outcome

Title	Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)
Description	Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered a positive lesion for prostate cancer.The measure would be compared with other imaging or pathology.
Time Frame	1 hour and 2 hour timepoints at baseline

Outcome Measure Data

Analysis Population Description

In Arm 1: 3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue. Arm 2: 1 patient had technical issues and was not included in the final analysis Arm 3: 2 patients were not imaged and 1 patient withdrew consent

Arm/Group Title	Suspected Localized Prostate Cancer	Biochemical Recurrence	Known Metastatic Disease
Arm/Group Description	Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater. N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Patients with biochemical prostate cancer relapse after definitive treatment 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging. 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Measure Participants	13	68	28
Number [lesions]	9	79	140

3. Secondary Outcome

Title	Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Description	Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame	Date treatment consent signed to date off study, approximately 42 months and 21 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suspected Localized Prostate Cancer	Biochemical Recurrence	Known Metastatic Disease
Arm/Group Description	Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater. N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Patients with biochemical prostate cancer relapse after definitive treatment 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.	Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging. 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Measure Participants	16	69	31
Count of Participants [Participants]	1 6.3%	3 4.3%	8 25.8%

4. Secondary Outcome

Title	Number of Detectable Lesions in Bone With Respect to 18F-DCFBC Imaging and/or Na18F Positron Emission Tomography (PET)/Computed Tomography (CT) in Patients With Known Metastatic Disease
Description	18F-DFBC and conventional imaging was used to identify positive lesions in bone.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

The Suspected Localized Prostate Cancer and Biochemical Recurrence Arms/Groups are not applicable for this outcome measure, thus are not represented here. Data was collected for 31 participants but only 28 had data evaluable for final analysis in the Known Metastatic Group.

Arm/Group Title	Known Metastatic Disease
Arm/Group Description	Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging. 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Measure Participants	28
Measure lesions	241
Number [number of bone lesions]	185

5. Secondary Outcome

Title	Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH)
Description	Primary prostate cancer was compared to BPH nodules and normal prostate tissue using a one-way analysis of variance (Anova). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or blood pool for lymph nodes.
Time Frame	1 hour and 2 hour post injection (p.i.)

Outcome Measure Data

Analysis Population Description

3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue. The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.

Arm/Group Title	Suspected Localized Prostate Cancer
Arm/Group Description	Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater. N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Measure Participants	13
Primary prostate tumor - 1 hour post injection	5.8 (4.4)
BPH nodules - 1 hour post injection	2.1 (0.3)
Normal prostate - 1 hour post injection	2.1 (0.4)
Primary prostate tumor - 2 hour post injection	5.9 (5.3)
BPH nodules - 2 hour post injection	2.0 (0.36)
Normal prostate tumor - 2 hour post injection	2.0 (0.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Suspected Localized Prostate Cancer
	Comments	At 1 hour post injection.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0033
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Suspected Localized Prostate Cancer
	Comments	At 2 hour post injection.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	ANOVA
	Comments

6. Secondary Outcome

Title	Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy
Description	Tissue was obtained and stained with hematoxylin-eosin. The resulting whole mount specimens were correlated with MRI and PET/CT imaging. For each dominant/index tumor (largest tumor with highest Gleason score) was determined.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

3 patients were excluded from analysis, because of prior focal laser ablation therapy (n=1), prior brachytherapy (n=1), and lack of histopathology confirmation tissue (n=1). The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.

Arm/Group Title	Suspected Localized Prostate Cancer
Arm/Group Description	Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater. N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Measure Participants	13
Measure Tumor foci	25
Median (Full Range) [cm]	1.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Suspected Localized Prostate Cancer
	Comments
	Type of Statistical Test	Equivalence
	Comments	One way analysis variance.
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	variance
	Comments

7. Secondary Outcome

Title	Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland
Description	Visualizing positive lesions with DCFBC and mpMRI.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

3 patients were excluded from analysis, because of prior focal laser ablation therapy (n=1), prior brachytherapy (n=1), and lack of histopathology confirmation tissue (n=1). The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.

Arm/Group Title	Suspected Localized Prostate Cancer
Arm/Group Description	Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater. N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Measure Participants	13
Measure lesions	25
18F-DCFBC	36
mpMRI	96

8. Secondary Outcome

Title	Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group
Description	Visualizing positive lesions as a function of PSA value. Undetectable PSA is normal in this population.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

1 patient had technical issues and was not included in the final analysis.

Arm/Group Title	Biochemical Recurrence
Arm/Group Description	Patients with biochemical prostate cancer relapse after definitive treatment 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Measure Participants	68
<0.5 ng/mL	15
0.5 to <1.0 ng/mL	46
1.0 to 2.0 ng/mL	83
2.0 ng/mL	77

Adverse Events

Time Frame	Date treatment consent signed to date off study, approximately 42 months and 21 days.
Arm/Group Title	Suspected Localized Prostate Cancer		Biochemical Recurrence		Known Metastatic Disease
Arm/Group Description	Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater. N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.		Patients with biochemical prostate cancer relapse after definitive treatment 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.		Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging. 18F DCFBC: Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
All Cause Mortality
	Suspected Localized Prostate Cancer		Biochemical Recurrence		Known Metastatic Disease
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/69 (0%)		2/31 (6.5%)
Serious Adverse Events
	Suspected Localized Prostate Cancer		Biochemical Recurrence		Known Metastatic Disease
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		1/69 (1.4%)		4/31 (12.9%)
Gastrointestinal disorders
Gastrointestinal disorders - Other, nausea	0/16 (0%)	0	1/69 (1.4%)	1	0/31 (0%)	0
General disorders
Death NOS	0/16 (0%)	0	0/69 (0%)	0	2/31 (6.5%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death	0/16 (0%)	0	0/69 (0%)	0	1/31 (3.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0/16 (0%)	0	0/69 (0%)	0	1/31 (3.2%)	1
Vascular disorders
Thromboembolic event	0/16 (0%)	0	1/69 (1.4%)	1	0/31 (0%)	0
Other (Not Including Serious) Adverse Events
	Suspected Localized Prostate Cancer		Biochemical Recurrence		Known Metastatic Disease
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)		3/69 (4.3%)		8/31 (25.8%)
Blood and lymphatic system disorders
Anemia	0/16 (0%)	0	0/69 (0%)	0	2/31 (6.5%)	2
General disorders
Pain	1/16 (6.3%)	1	1/69 (1.4%)	1	0/31 (0%)	0
Fever	0/16 (0%)	0	1/69 (1.4%)	1	0/31 (0%)	0
Investigations
Alkaline phosphatase increased	0/16 (0%)	0	0/69 (0%)	0	1/31 (3.2%)	1
Blood bilirubin increased	0/16 (0%)	0	0/69 (0%)	0	1/31 (3.2%)	1
Investigations - Other, near syncope	0/16 (0%)	0	0/69 (0%)	0	1/31 (3.2%)	1
Lymphocyte count increased	0/16 (0%)	0	0/69 (0%)	0	1/31 (3.2%)	1
Platelet count decreased	0/16 (0%)	0	0/69 (0%)	0	2/31 (6.5%)	2
Metabolism and nutrition disorders
Hyperkalemia	0/16 (0%)	0	0/69 (0%)	0	1/31 (3.2%)	1
Hypernatremia	0/16 (0%)	0	0/69 (0%)	0	1/31 (3.2%)	1
Hypophosphatemia	0/16 (0%)	0	0/69 (0%)	0	1/31 (3.2%)	1
Renal and urinary disorders
Urinary retention	0/16 (0%)	0	1/69 (1.4%)	1	0/31 (0%)	0
Urinary tract pain	0/16 (0%)	0	1/69 (1.4%)	1	0/31 (0%)	0
Urinary urgency	0/16 (0%)	0	1/69 (1.4%)	1	0/31 (0%)	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.