PET/MR Imaging for Prostate Cancer

(PSMA-DOCS Trial)

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Mr contraindication, Gadolinium contraindication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

56 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Currently, patients suspected of having prostate cancer undergo ultrasound-guided systematic biopsies of the prostate. However, up to a quarter of clinically significant tumors, which may pose a risk to patient's well-being, may be missed on random biopsies. MRI enables detection of further tumors in this patient population, but also has limited accuracy. Study hypothesis: We hypothesize that hybrid PET-MRI, a novel scanner which incorporates MRI with molecular imaging will improve the detection rate of clinically significant tumors. Study design: In this prospective trial, we will recruit 57 men who are suspected of having prostate cancer but have had negative systematic biopsies, who have been diagnosed with low-risk disease but have clinically signs of more aggressive tumor or who have a focal tumor detected and are candidates for minimally-invasive tumor ablation (=tumor destruction with laser or ultrasound waves), in whom it is crucial to exclude other tumor sites. All patients will undergo PET/MRI after injection of a radiopharmaceutical called "18F-DCFPyL". This is a radioactive probe which has been shown in preliminary studies to be sensitive and specific for detection of prostate cancer. All lesions detected on PET/MRI will undergo biopsy under ultrasound using fused PET/MRI and ultrasound images for guidance, and compared to histopathology. The primary outcome measure in this study is the proportion of clinically significant prostate cancers that are detected with PET/MRI compared to MRI alone. Improved detection of clinically significant prostate cancer may enable a tailored, personalized therapeutic approach, decreasing morbidity and potentially improving overall patient outcome.

Eligibility Criteria

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.

Inclusion Criteria

I am suspected to have prostate cancer despite a negative biopsy or my low-risk cancer might be more serious.

Potential candidates for FT (as per institutional guidelines).

Participants must meet one of the following requirements:

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET/MRI Imaging

All patients undergo PET/MRI after injection of 18F-DCFPyL to detect prostate cancer lesions

1 day

1 visit (in-person)

Biopsy

Lesions detected on PET/MRI undergo biopsy using fused PET/MRI and ultrasound images for guidance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after biopsy and imaging

up to 2 years

Treatment Details

Interventions

• 18F-DCFPyL
• PET/MR-ultrasound guided Fusion biopsy
• Systemic TRUS guided biopsy

Trial Overview 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.

Participant Groups

Group I: No focal biopsy needed Experimental Treatment 1 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 biopsy Experimental Treatment 1 Intervention

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

18F-DCFPyL is already approved in United States, European Union for the following indications:

Approved in United States as PyL-PSMA-11 for:

• Detection of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

Approved in European Union as 18F-DCFPyL for:

• Diagnostic imaging in men with prostate cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+