Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03976843|
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : July 13, 2020
People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery.
To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this approach is better or worse than the usual approach for prostate cancer.
Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread
Participants will be screened with:
- Medical history
- Blood tests
- CT and MRI scans: Participants will lie in a machine. The machine will take pictures of the body.
- Bone scan
Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of their whole body 60 90 minutes later. During the scan, they will lie on their back and stay still.
Within 60 days after the scan, participants will have surgery. This will remove the prostate gland and lymph nodes around it. Some tissue will be used for genetic testing.
If the PET/CT scan suggests the cancer has spread, participants may need to have another biopsy within 60 days after the scan.
After surgery, participants will have follow-up visits for 5 years. They will have 5 visits the first year and 2 the second. Then they will have visits once a year.
If participants cancer returns, they will have repeat PET/CT scans.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 18F-DCFPyL||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate Cancer|
|Actual Study Start Date :||December 4, 2019|
|Estimated Primary Completion Date :||August 31, 2025|
|Estimated Study Completion Date :||August 31, 2025|
Experimental: 1/18F-DCFPyL PET/CT + radical prostatectomy
18F-DCFPyL PET/CT with radical prostatectomy andlymphadenectomy
18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging
- progression free survival [ Time Frame: 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years ]progression-free survival which is improved over that of historical data from a general population
- progression free survival [ Time Frame: 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years ]progression-free survival of patients with an 18F-DCFPyL PET/CT that is positive for metastases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976843
|Contact: Michele L Reed (Diffenderfer), R.N.||(240) email@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Imelda Tenggara (415) 353-7.48 firstname.lastname@example.org|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70112-2699|
|Contact: Charlotte Manogue 504-988-3908 email@example.com|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Rana Harb 410-502-5500 firstname.lastname@example.org|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|United States, Massachusetts|
|Brigham and Women s Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Anjali Vasavada 617-732-5153 email@example.com|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Emma Zulch 646-888-1331 firstname.lastname@example.org|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107-6541|
|Contact: Christine Hubert 215-955-9954 email@example.com|
|Principal Investigator:||William L Dahut, M.D.||National Cancer Institute (NCI)|