Prostate Specific Membrane Antigen (PSMA)-Based PET Imaging of High Risk Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03976843|
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : July 19, 2019
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|
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- About 30,000 men will die from prostate cancer in the US in 2018. The majority of these men originally presented with localized cancer.
- Treatment options for patients with high risk, localized disease typically involve radical prostatectomy (RP) or radiation therapy (RT) in combination with androgen deprivation therapy (ADT). Following RP, 70% of patients with high-risk disease will experience a biochemical recurrence at 5 years, and approximately 20% will die of their disease in 10-15 years, likely due to metastatic disease that was not detectable using conventional imaging (99mTc-methylene diphosphonate bone scan and X-ray computed tomography) at
the time of prostatectomy.
- Prostate-specific membrane antigen (PSMA) is commonly expressed in prostate cancers and is associated with biologic aggressiveness.
- The second generation, PET tracer 18F-DCFPyl binds to the enzymatic portion of PSMA. It exhibits high uptake in tumor and rapid washout in normal tissues leading to high tumor to background ratios and the possibility of detecting metastases when conventional imaging is negative.
-To determine if patients with a preoperative 18F-DCFPyL PET/CT that is negative for metastases experience 5 year progression free survival (PFS) which is improved (40%) over that of historical data (30%) based on a general population of similar patients who have not undergone imaging with 18F-DCFPyL PET/CT
- Men greater than or equal to 18 years of age at the time of providing informed consent.
- Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory
- Eastern Cooperative Oncology Group (ECOG) performance status: less than or equal to 2.
Must have prostate cancer with high risk features defined as:
- Gleason 8 and higher OR
- PSA > 20 ng/mL OR
- Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b
- Hemoglobin >= 9 g/dL
- Leukocytes >=3,000/mcL
- Platelets >=100,000/mcL
- Total bilirubin <2 X normal institutional limits
- AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits
- Creatinine <2 X normal institutional limits OR
- eGFR >=50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (calculated via the MDRD equation)
- Patients must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT.
- Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT
- This is an open-label, non-randomized, multi-center trial designed to evaluate the impact of 18F-DCFPyL PET/CT imaging on Progression-Free Survival at 5 years in patients with high risk localized prostate cancer.
- All subjects meeting eligibility criteria will undergo baseline assessments to include multiparametric MRI of the prostate, 99mTc-methylene diphosphonate bone scan and contrast-enhanced CT of the abdomen and pelvis.
- All subjects meeting eligibility criteria will undergo 18F-DCFPyL PET/CT.
- The study will enroll up to 200 patients from 7 centers. Up to 40 patients will be enrolled at NCI.
- All subjects will undergo radical prostatectomy and lymphadenectomy within 60 days following PET/CT imaging.
- Subjects will be evaluated at 6 weeks, at 3, 6, 9, 12, and 18 months, at 2, 3, 4, and 5 years post-prostatectomy to determine if there has been progression and to record details of subsequent treatment and response.
- 18F-DCFPyL PET/CT imaging will be repeated at the time of progression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer|
|Estimated Study Start Date :||July 24, 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
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: Guinevere Chun, R.N.||(240) email@example.com|
|United States, California|
|University of California, San Francisco||Not yet recruiting|
|San Francisco, California, United States, 94143|
|Contact: Imelda Tenggara (415) 353-7.48 firstname.lastname@example.org|
|United States, Louisiana|
|Tulane University||Not yet recruiting|
|New Orleans, Louisiana, United States, 70112-2699|
|Contact: Charlotte Manogue 504-988-3908 email@example.com|
|United States, Maryland|
|Johns Hopkins University||Not yet recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Rana Harb 410-502-5500 firstname.lastname@example.org|
|National Institutes of Health Clinical Center||Not yet 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|
|Dana Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Anjali Vasavada 617-732-5153 email@example.com|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Not yet recruiting|
|New York, New York, United States, 10021|
|Contact: Emma Zulch 646-888-1331 firstname.lastname@example.org|
|United States, Pennsylvania|
|Thomas Jefferson University||Not yet 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)|