Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03404648
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arm: 1
• Actual Duration (Months): 26.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to find out if a PET/MR scan in combination with standard MRI and CT scans can improve the early detection and treatment of patients with prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Adenocarcinoma	Drug: C-11 choline PET tracer; Drug: Gadobutrol; Device: PET/MR scanner	Phase 3

Detailed Description

High risk prostate cancer patients will undergo C11-Choline PET/MR whole body fusion scan and pelvic mpMRI for accurate staging. The PET/MR imaging findings, including the primary lesion with the prostate bed and pelvic lymph nodes, will be correlated with the histopathologic result. Researchers aim to provide accurate one-stop shopping opportunity in diagnosis and staging of high risk prostate cancer using the C11-choline PET/MR scan.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Staging of Untreated Patients With Very High-risk and High-risk Prostate Carcinoma Utilizing Hybrid C11-choline PET/MR and Pelvic Multiparametric MRI for Personalized Precise Treatment: a Pilot Study
• Actual Study Start Date: Nov 1, 2017
• Actual Primary Completion Date: Jan 23, 2020
• Actual Study Completion Date: Jan 23, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: High Risk Prostate Cancer Patients Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).

Drug: C-11 choline PET tracer; C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.; Other Names: Choline C-11 Injection ; Drug: Gadobutrol; Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.; Other Names: Gadavist ; Device: PET/MR scanner; C11-PET/MR and pelvic mpMRI scan for prostate cancer.; Other Names: GE SIGNA 3T PET/MR scanner

Outcome Measures

Primary Outcome Measures

1. Uptake Value of C11-choline [Baseline]

   Measured by maximum standardized uptake value (SUVmax) of indexed lesions. SUV is calculated as ratio of concentration of tissue reactivity divided by dose at time of injection divided by body weight.

2. Number of Lesions Showing C11-Choline Uptake [Baseline]

   Measured by the mean number of lesions to show C11-Choline uptake.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Untreated patients with high-risk and very high-risk prostate cancer, who require clinical pelvic mpMRI, CT, and bone scan as standard clinical care for diagnosis and management of prostate cancer.

Exclusion Criteria:

1. Patients who already received primary treatment or neo-adjuvant therapy.

2. Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI, CT, bone scan) for staging. Reimbursement of pelvic mpMRI in this study is denied. CT and bone scan may be done elsewhere outside of Mayo Clinic but should be of diagnostic quality. Research C-11 choline PET/MR will not substitute pelvic mpMRI, CT, or bone scan in this study.

3. Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm, involuntary movement [e.g., tremor, dystonia]).

4. Patients have total hip arthroplasty (THA), which can cause substantial susceptibility artifact and degrade image quality of mpMRI.

5. Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.

6. Patients have contraindication to gadolinium based MR contrast agents (e.g., renal failure, severe reaction to gadolinium based MR contrast agents). Epidermal growth factor receptor (eGFR) should be above 30 within 30 days the time of mpMRI.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Ming Yang, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 3, 2019

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Ming Yang, M.D., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03404648
• Other Study ID Numbers: 16-007897
• First Posted: Jan 19, 2018
• Last Update Posted: Feb 8, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ming Yang, M.D., Principal Investigator, Mayo Clinic: high risk; prostate cancer; C11-choline; PET/MR; mpMRI
• Additional relevant MeSH terms: Adenocarcinoma; Choline

Study Results

Participant Flow

Arm/Group Title	High Risk Prostate Cancer Patients
Arm/Group Description	Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI). C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table. Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously. PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer.
Period Title: Overall Study
STARTED	19
COMPLETED	19
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	High Risk Prostate Cancer Patients
Arm/Group Description	Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI). C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table. Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously. PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer.
Overall Participants	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.9 (6.0)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	19 100%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	19 100%

Outcome Measures

1. Primary Outcome

Title	Uptake Value of C11-choline
Description	Measured by maximum standardized uptake value (SUVmax) of indexed lesions. SUV is calculated as ratio of concentration of tissue reactivity divided by dose at time of injection divided by body weight.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Prostate Cancer Patients
Arm/Group Description	Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI). C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table. Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously. PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer.
Measure Participants	19
Mean (Standard Deviation) [Ratio]	6.2 (1.8)

2. Primary Outcome

Title	Number of Lesions Showing C11-Choline Uptake
Description	Measured by the mean number of lesions to show C11-Choline uptake.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Prostate Cancer Patients
Arm/Group Description	Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI). C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table. Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously. PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer.
Measure Participants	19
Mean (Standard Deviation) [Lesions]	1.2 (0.4)

Adverse Events

Time Frame	Adverse events were collected from baseline to end of study participation for a total of approximately 2 days on all participants.
Arm/Group Title	High Risk Prostate Cancer Patients
Arm/Group Description	Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI). C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table. Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously. PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer.
All Cause Mortality
	High Risk Prostate Cancer Patients
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Serious Adverse Events
	High Risk Prostate Cancer Patients
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	High Risk Prostate Cancer Patients
	Affected / at Risk (%)	# Events
Total	0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.