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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

Must not have

Documented, clear-cut metastatic disease on conventional workup where PET findings would not potentially alter patient management

Inability to lie still for PET/CT or PET/MR examination

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is high risk or unfavorable intermediate-risk.

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I am 18 years old or older.

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I have been diagnosed with prostate cancer.

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My prostate cancer has returned or persisted after initial treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has clearly spread, and a PET scan won't change my treatment plan.

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I cannot stay still for PET scans.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

18F-DCFPyL PET changes the detection of lymph node and distant metastases

Side effects data

From 2019 Phase 3 trial • 208 Patients • NCT03739684

Headache

Hypertension

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

18F-DCFPyL Injection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~600

0 / 6Eligibility criteria met