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

Official Title

PROPS (PET/MRI Pre-Radiotherapy for Post-Prostatectomy Salvage)

Summary:

The PROPS trial is for men being considered for radiation therapy 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 radiation therapy 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.

Trial Description

Primary Outcome:

  • 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
Secondary Outcome:
  • Biochemical disease free survival at 3 years post-treatment
The study will be a non-randomized, prospective study of men with suspected local recurrence of prostate cancer post-prostatectomy with negative conventional re-staging studies (bone scan and CT of the abdomen and pelvis; MRI of the pelvis as part of re-staging is allowed where it is the institutional standard of care). The clinician will develop an initial treatment plan based on conventional re-staging information. Patients enrolled onto trial will undergo hybrid PET/MR imaging using 18F-FCH (sites without access to a hybrid PET/MR scanner will conduct a 18F-FCH PET/CT in addition to a full body MRI). A consensus staging report based on local and centralized review of the 18F-FCH PET imaging will be provided to the attending clinician, who will document a second treatment plan based on this additional information. The treatment plan to be implemented (initial or second) will be left to clinician discretion, but will be documented.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society