PSMA-PET Registry for Recurrent Prostate Cancer (NCT03718260) | Clinical Trial Compass
CompletedNot Applicable
PSMA-PET Registry for Recurrent Prostate Cancer
Canada9,684 participantsStarted 2018-09-27
Plain-language summary
This study aims to institute a province-wide registry leveraging the availability of a new Positron Emission Tomography tracer, \[18F\]-DCFPyL and PET expertise across Ontario centers to improve our ability to characterize patterns of recurrence and personalize therapies in men with recurrent prostate cancer after primary treatment.
Who can participate
Age range
18 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
. Written informed consent obtained
. Male, Age ≥ 18 years
. Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer. Unless PET/CT requested as part of Cohort 7.
. Suspected persistent or recurrent disease defined as one of the following (unless PET/CT requested as part of Cohort 7):
. High risk disease at the time of radical prostatectomy characterized by pathologically involved node(s) or persistently detectable PSA (\>0.1ng/ml) within 3 months post-surgery
. Primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following:
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
Frequency of disease detection on PSMA PET
Timeframe: 5 years
2
To determine the proportion of men who have "actionable disease" identified on PSMA PET with [18F]-DCFPyL or [18F]PSMA-1007.
Timeframe: 5 years
Trial details
NCT IDNCT03718260
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
. Patient scenario falls into one of the 7 pre-defined cohorts. When patient scenario falls outside cohorts 1-6 participation in the Registry must be approved through the established CCO adjudication process for Cohort 7.
. Karnofsky performance status 70 or better (ECOG 0, 1).
Exclusion criteria
. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components.
. Prior PSMA PET scan within 6 months of enrollment.
. Patient cannot lie still for at least 60 minutes or comply with imaging.
. Patients falling outside of Cohorts 1-6 where independent adjudication by CCO does not support participation in the Registry.
. Written informed consent obtained
. Male, Age ≥ 18 years
. Biopsy proven, clinically high risk (cT3, PSA ≥20, biopsy Gleason Grade Group 4-5) prostate cancer undergoing initial staging prior to primary treatment with surgery or radiotherapy
. Patient scenario falls into one of the 8 pre-defined cohorts. When patient scenario falls outside cohorts 0-6 and 8, participation in the Registry must be approved through the established CCO adjudication process for Cohort 7.