Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer (NCT03976843) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer
United States175 participantsStarted 2019-12-04
Plain-language summary
Background:
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.
Objective:
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.
Eligibility:
Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread
Design:
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.
Who can participate
Age range
18 Years – 99 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory.
* 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
* Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT
* Men age greater than or equal to 18 years.
* ECOG performance status \<2
* Patients must have adequate organ and marrow function as defined below:
* Hemoglobin greater than or equal to 9 g/dL
* leukocytes greater than or equal to 3,000/mcL
* platelets greater than or equal to 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 greater than or equal to 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
* Ability of subject to understand and the willingness to sign a written informed consent document.
* Willingness and ability to undergo biopsy of radiotracer-avid lesion if feasible.
* Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT
EXCLUSION CRITERIA:
* Any investigational agents in the past 28 days prior to enrollment.
* Clinical stage T4 (tumor invades adjacent structures except seminal …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
progression free survival
Timeframe: 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years