NCT03234556

Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA

Diagnosing Clinically Significant Prostate Cancer in African American and White Men Phase II, Randomized Clinical Trial, Multi-center, MR-Guided vs. 12-core Systematic Random Biopsy, Localized Prostate Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To compare the detection of clinically significant prostate cancer (CSPCa) in Arm 1 versus Arm 2. II. To compare between African American (AA) and white men the probability of developing CSPCa within three years of initial biopsy at the start of the study. SECONDARY OBJECTIVES: I. To determine complications and patient morbidity associated with either systematic random prostate biopsy (SR-Bx) versus (vs) magnetic resonance imaging-ultrasound image fusion biopsy (MRUS-Bx) + SR-Bx. TERTIARY OBJECTIVES: I. To compare Gleason score between MRUS-Bx and radical prostatectomy (RP) specimen among men who elect RP (\~110 in the randomized controlled trial \[RCT\]). II. To assess within Arm 1 the detection of CSPCa three months after SR-Bx among men initially diagnosed with clinically insignificant prostate cancer (CinsPCa) or no cancer. III. To identify among men invited to participate and those actually enrolled in the RCT: determinants of study participation. IV. To identify among men invited to participate and those actually enrolled in the RCT: determinants of treatment decision (active surveillance \[AS\] vs radiation vs RP) including the diagnostic method. OUTLINE: Patients are randomized into 1 of 2 arms. ARM I: SR-Bx group * Patients undergo SR-Bx * If SR-Bx doesn't reveal clinically significant cancer, then MRI 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. ARM II: MRUS-Bx group * Patients undergo MRI. Must be scheduled at least 1 day before MRUS Biopsy. * MRI shows no lesion present (PIRADS 1-2): no MRUS-Bx, schedule for SR-Bx only. * MRI lesion present (PIRADS ≥ 3): schedule for MRUS-Bx, which will be done first and followed immediately after by SR-Bx. FOLLOW UP: After completion of procedure, patients are followed up at 2-4 weeks, 3, 6, 9, and 12 months, and then periodically for up to 5 years.

Conditions

• Health Status Unknown
• Elevated PSA

Interventions

Type	Name	Description
PROCEDURE	Biopsy of Prostate	Undergo SR-Bx
OTHER	Laboratory Biomarker Analysis	Correlative studies
DIAGNOSTIC_TEST	Magnetic Resonance Imaging	Undergo MRI
DIAGNOSTIC_TEST	MRI Ultrasound Fusion Guided Biopsy	Undergo MRUS-Bx

Timeline

• Start date: 2017-09-25
• Primary completion: 2026-06-30
• Completion: 2028-05-23
• First posted: 2017-07-31
• Last updated: 2025-12-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study