Clinical trial · Interventional
PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-Prostatectomy
PROPS (PET/MRI Pre-Radiotherapy for Post-Prostatectomy Salvage)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FCH PET/MRI Scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-FCH PET/MRI Scan
- description
- Patients will undergo an injection of 18F-fluoromethyl-choline at 3.6 MBq/kg followed by whole body PET/CT imaging. Patients will also undergo a whole body MRI including T2 weighted, Diffusion weighted and Gadolinium Contrast Enhanced sequences. Patients with suspicion for recurrence may undergo biopsy if lesions identified on PET/CT or MRI are accessible for biopsy
- interventionNames
- Device: 18F-FCH PET/MRI Scan
Primary outcomes (1)
- measure
- 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
Secondary outcomes (1)
- measure
- Biochemical disease free survival at 3 years post-treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 other conditions affecting imaging or delivery of therapeutic radiation * Contraindication to MRI, including but not restricted to: pacemaker or other electronic implants, known metal in the orbit, MR incompatible surgical or cerebral aneurysm clips, Shrapnel, tattoos, non-removable body piercings (relative contraindications) * Hormone Androgen deprivation therapy of any type within 6 months prior to enrollment
References
Publications (0)
Data not yet available