CompletedNot Applicable

PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-Prostatectomy

Australia, Canada99 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 range18 Years

SexMALE

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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…

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01