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PSMA PET Scan for Prostate Cancer (PM-PPR Trial)
N/A
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Staging of patients with high risk disease (Gleason ≥8, ≥T3 disease, PSA >20 ng/ml) or unfavourable intermediate-risk disease
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion up to 5 years
Awards & highlights
PM-PPR Trial Summary
This trial will help determine if PSMA PET is more accurate than the current standard of care for staging or restaging prostate cancer.
Who is the study for?
Men over 18 with prostate cancer, either being initially staged for high-risk or unfavorable intermediate-risk disease, or restaged due to unclear results from standard tests. Eligible men must have a histologic diagnosis and be fit for PET scans. Men with clear-cut metastatic disease not benefiting from PET findings are excluded.Check my eligibility
What is being tested?
The trial is evaluating the effectiveness of PSMA PET imaging (using PET/MR or PET/CT) in improving the staging and restaging process for prostate cancer management. It's a single-arm study involving 200 men who will receive this imaging alongside standard treatments.See study design
What are the potential side effects?
As this trial focuses on diagnostic imaging rather than treatment, side effects may include discomfort during the scan, allergic reactions to tracers used in the imaging process, and potential risks associated with radiation exposure.
PM-PPR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is high risk or unfavorable intermediate-risk.
Select...
I am 18 years old or older.
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I have been diagnosed with prostate cancer.
Select...
My prostate cancer has returned or persisted after initial treatment.
PM-PPR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
18F-DCFPyL PET changes the detection of lymph node and distant metastases
Side effects data
From 2019 Phase 3 trial • 208 Patients • NCT037396841%
Headache
1%
Fatigue
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
18F-DCFPyL Injection
PM-PPR Trial Design
1Treatment groups
Experimental Treatment
Group I: 18F-DCFPyL PET/ MR or PET/CT imagingExperimental Treatment1 Intervention
Will use a newer technology called PET-MR that combines a Positron Emission Tomography (PET) scan with Magnetic Resonance Imaging (MRI) scan. This new combined imaging test, where PET and MRI data is gathered at one time, will be performed on an integrated PET-MR scanner located at Toronto General Hospital.
Or technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data is gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre.
Choice of imaging method (PET/CT or PET/MR) will be made by one of the study PIs, based on clinical judgement taking into account the specific exam indication, prior recent imaging, and suitability for MR imaging.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-DCFPyL
2019
Completed Phase 3
~350
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,290 Total Patients Enrolled
64 Trials studying Prostate Cancer
15,400 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is high risk or unfavorable intermediate-risk.My cancer has clearly spread, and a PET scan won't change my treatment plan.I am 18 years old or older.I have been diagnosed with prostate cancer.I cannot stay still for PET scans.My prostate cancer has returned or persisted after initial treatment.My prostate cancer diagnosis is unclear after standard tests.
Research Study Groups:
This trial has the following groups:- Group 1: 18F-DCFPyL PET/ MR or PET/CT imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it feasible for more participants to join this trial?
"The clinicaltrials.gov database shows that this trial, which was first publicized on the 27th of April 2018 before receiving a last update on October 31st 2022 is no longer recruiting patients. Fortunately, there are 1252 other studies actively enrolling participants currently."
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