PET/MR Imaging for Prostate Cancer (PSMA-DOCS 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess whether a new type of scanner that uses MRI with molecular imaging can improve the detection of clinically significant tumors in men suspected of having prostate cancer.

Who is the study for?

This trial is for men suspected of having prostate cancer who've had negative systematic biopsies, those diagnosed with low-risk disease but showing signs of a more aggressive tumor, or candidates for minimally-invasive tumor ablation needing confirmation of the tumor's extent.

What is being tested?

The study tests if PET/MRI scans using a radioactive probe called '18F-DCFPyL' can better detect clinically significant prostate cancers compared to MRI alone. Detected lesions will be biopsied using image guidance to confirm accuracy.

What are the potential side effects?

Potential side effects may include reactions to the radiopharmaceutical like nausea or rash, discomfort from the biopsy procedure, and typical risks associated with exposure to radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 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

Rate of clinically significant prostate cancer (csPCa) detected in the study population by 18F-DCFPyL-PET/mpMR as compared to mpMR alone

Secondary study objectives

Change in eligibility for focal therapy according to each modality

Correlation of tumor grade to PSMA expression on PET (SUV).

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: No focal biopsy neededExperimental Treatment1 Intervention

Patients in which PET/MR have found no focal findings, will undergo a systemic biopsy as per standard of care, without specific cores for study purposes (Systemic TRUS guided biopsy)

Group II: Focal biopsyExperimental Treatment1 Intervention

Patients with a suspicious focal finding on PET/MR, will undergo systemic+focal or focal fusion biopsy (PET/MR-ultrasound guided Fusion biopsy)

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