PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-P… (NCT02131649) | Clinical Trial Compass
CompletedNot Applicable
PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-Prostatectomy
Australia, Canada, United Kingdom99 participantsStarted 2015-02
Plain-language summary
The PROPS trial is for men being considered for radiotherapy due to the suspicion that their prostate cancer has recurred following the surgical removal of their prostate (prostatectomy). This suspicion is based on rises seen on Prostate Specific Antigen (PSA) blood tests. Only men who demonstrate the absence of disease on standard imaging scans (Computed Tomography (CT) and bone scans) will be invited to participate.
This study will be assessing if the imaging probe 18-F Fluorocholine (18F-FCH) used during Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) scans, can better predict who will benefit from radiotherapy by identifying the source of cancer recurrence. This will be determined by measuring the number of men who have disease identified outside of the prostate bed (the small pocket or depression where the prostate used to be) on their 18F-FCH PET scan. Since F-18-FCH has been shown to be more sensitive in detecting prostate cancer that may have spread into lymph nodes or bone, it may potentially identify areas of prostate cancer spread not seen with standard imaging.
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:
* Male, aged 18 years or older.
* Confirmation of prostate cancer on prostatectomy pathology report.
* No lymph node involvement (N0 or Nx) reported on prostatectomy pathology report.
* Documented PSA rise measured on 3 occasions.
* PSA ≥ 0.2 ng/ml at enrolment.
* At least one adverse feature: Current PSA \> or equal to 1.0, Initial Gleason Grade \> or equal to 8, Positive surgical margin, pT3b (seminal vesicle involvement), or PSA doubling time \< 10 months.
* Bone scan and CT scan within 12 weeks of enrolment negative or equivocal for metastatic disease.
* Suitable candidate for radiotherapy and not yet had any salvage treatment post-prostatectomy.
Exclusion Criteria:
* Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components.
* Proven metastatic disease.
* Patients who refuse salvage prostate bed radiotherapy.
* Patients who refuse to join the trial or are unable to consent.
* Patients not being considered for further therapy.
* Patients who cannot lie still for at least 30 minutes or comply with imaging.
* Unequivocal evidence of disease outside the prostate bed on conventional imaging
* Allergy to MRI contrast agent (exclusion for MRI component only) or PET tracer to be used as part of the imaging
* Sickle cell disease or other anemias
* Insufficient renal function (eGFR \< 30 mL/min/1.73 m2)
* Residual bladder volume \> 150 cc (determined by post-void ultrasound)
* Hip prosthesis, vascular grafting or ot…
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
Proportion of men with negative or equivocal conventional restaging imaging (bone scan + CT scan of abdomen and pelvis) with uptake identified outside of the prostate bed on 18F-FCH PET
Timeframe: Within 2 weeks of 18F-FCH PET scan
Trial details
NCT IDNCT02131649
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's