The Safety and Efficacy of 18F-Fluoromethylcholine (18F-FCH) PET/CT in Prostate Cancer (NCT02840552) | Clinical Trial Compass
CompletedPhase 3
The Safety and Efficacy of 18F-Fluoromethylcholine (18F-FCH) PET/CT in Prostate Cancer
Canada60 participantsStarted 2016-09
Plain-language summary
The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to establish our ability to reproduce results from the literature using FCH-PET/CT as a diagnostic and decision making tool in the management in two predefined groups of prostate cancer patients, specifically, biochemical recurrence and high risk staging. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a per-patient and per-lesion basis.
Who can participate
Age range
18 Years – 120 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.
Global Inclusion Criteria:
* Resident of Canada
* Male sex
* Age 18 years or older
* Previously diagnosed with prostate cancer, under referring physician's care
* ECOG performance status 0 - 3, inclusive
* Able to understand and provide written informed consent
* Able to tolerate the physical/logistical requirements of completing a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection
Global Exclusion Criteria:
* Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
* Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
* Patients who are claustrophobic.
Clinical Indication Criteria Subgroups:
* BCR: Biochemical recurrence as defined by serum PSA \> 1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management.
* HRS: Staging of high risk patients as defined by any one of the following:
* Gleason score \> 7
* Serum PSA \> 15 ng/ml
* T stage of T3 or greater on TNM staging
* Equivocal conventional staging such as CT, MRI or bone scan
* Clinical suspicion of advance stage disease (e.g. bone pain)
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
Safety of FCH-PET/CT imaging as measured by the incidence of adverse events (AE)
Timeframe: 7 days
2
Efficacy of FCH-PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth
Timeframe: 12 months
3
Efficacy of FCH-PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth
Timeframe: 12 months
Trial details
NCT IDNCT02840552
SponsorSir Mortimer B. Davis - Jewish General Hospital