PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-Prostatectomy (PROPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02131649|
Recruitment Status : Unknown
Verified March 2018 by Glenn Bauman, Lawson Health Research Institute.
Recruitment status was: Active, not recruiting
First Posted : May 6, 2014
Last Update Posted : March 13, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: 18F-FCH PET/MRI Scan||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PROPS (PET/MRI Pre-Radiotherapy for Post-Prostatectomy Salvage)|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2020|
Experimental: 18F-FCH PET/MRI Scan
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
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.
- 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 [ Time Frame: Within 2 weeks of 18F-FCH PET scan ]
- Biochemical disease free survival at 3 years post-treatment [ Time Frame: 3 years post-treatment ]Whether biochemical (PSA) control rates 3 years post-treatment are improved for participants with 18F-FCH PET imaging that was negative or demonstrated uptake confined to the prostate bed and received salvage pelvic radiotherapy compared to published results for men with adverse features.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131649
|Australia, New South Wales|
|St. Vincent's Hospital|
|Sydney, New South Wales, Australia, 2010|
|Peter MacCallum Cancer Centre|
|Melbourne, Victoria, Australia, 3002|
|Melbourne, Victoria, Australia, 3084|
|Melbourne, Victoria, Australia, 3128|
|Lawson Health Research Institute, London Health Sciences Centre|
|London, Ontario, Canada, N6A 5W9|
|University of Toronto|
|Toronto, Ontario, Canada, M5G 2M9|
|Universite Laval Quebec|
|Laval, Quebec, Canada, G1V 0A6|
|Velindre Cancer Centre|
|Cardiff, South Glamorgan, United Kingdom|
|University College London Hospital|
|London, United Kingdom, NW1 2BU|
|Royal Marsden Hospital|
|London, United Kingdom, SW3 6JJ|
|Principal Investigator:||Glenn Bauman, MD||London Regional Cancer Program|