NCT02131649

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	18F-FCH PET/MRI Scan	Patients will first undergo screening to ensure eligibility. If eligible, they will undergo a PET/MRI scan using 18F-FCH as the radiolabeled tracer. If prostate cancer is detected outside the prostate, patients may undergo a biopsy or follow-up 18F-FCH PET/MRI to confirm the results.

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-01-01
• Completion: 2021-01-01
• First posted: 2014-05-06
• Last updated: 2022-04-05

Locations

10 sites across 3 countries: Australia, Canada, United Kingdom