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Radiopharmaceutical

PET/MR-ultrasound guided Fusion biopsy 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
Clinical suspicion of PCa with negative TRUS-guided biopsy or clinically discordant low-risk PCa (suspicion of more extensive/aggressive disease).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 2 years
Awards & highlights

PSMA-DOCS Trial 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.Check my eligibility
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.See study design
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.

PSMA-DOCS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am suspected to have prostate cancer despite a negative biopsy or my low-risk cancer might be more serious.

PSMA-DOCS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of clinically significant prostate cancer (csPCa) detected in the study population by 18F-DCFPyL-PET/mpMR as compared to mpMR alone
Secondary outcome measures
Change in eligibility for focal therapy according to each modality
Correlation of tumor grade to PSMA expression on PET (SUV).

PSMA-DOCS 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)

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,743 Total Patients Enrolled
64 Trials studying Prostate Cancer
15,440 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby May 2024