Diagnostic Methods for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byInderbir Gill

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies how well systematic random biopsy or magnetic resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate cancer in patients with elevated prostate specific antigen. Systematic random biopsy and MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.

Eligibility Criteria

This trial is for African American and white men with elevated PSA levels (>2.5 ng/ml) who have either never had a prostate biopsy or had one negative biopsy, no palpable nodule on exam, and are in good health (ECOG status <=1). They must consent to the study's procedures and not have active bowel disease, recent chemo or radiotherapy for other conditions, unstable heart disease, severe psychiatric issues, inability to undergo MRI, or multiple prior biopsies.

Inclusion Criteria

I am willing to have imaging tests done before and after a prostate biopsy.

I have been mostly active and able to carry out all my pre-disease activities up to 3 months ago.

My PSA level is above 2.5 ng/ml and I have no lumps on prostate exam.

+5 more

Exclusion Criteria

Patients receiving any other investigational agents

Patients who had > 1 prior prostate biopsy

I've had chemotherapy or radiotherapy for a condition other than prostate cancer in the last year.

+4 more

Participant Groups

The trial is testing two methods of diagnosing prostate cancer in men with high PSA: systematic random biopsy versus MRI-ultrasound fusion guided biopsy. It aims to determine which method is more accurate for detection. Participants will be randomly assigned to one of these diagnostic approaches.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (MRI, MRUS-Bx, SR-Bx)Experimental Treatment4 Interventions

Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy. * If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only. * If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.

Group II: Arm I (SR-Bx)Active Control4 Interventions

Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.