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Systematic Random Biopsy or MRI-US Fusion Biopsy in Diagnosing Prostate Cancer in Patients With PSA Progression

2017-08-01 13:38:21 | BioPortfolio

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.

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: Patients undergo SR-Bx.

ARM II: Patients undergo MRI scans at least one day before prostate biopsy, three months after SR-Bx, and 12 months after initial MRI. Patients with no lesion present only undergo SR-Bx. Patients with a lesion present undergo MRUS-Bx followed by SR-Bx.

After completion of study, patients are followed up at 2-4 weeks, 3, 6, 9, and 12 months, and then periodically for up to 5 years.

Study Design

Conditions

Health Status Unknown

Intervention

Biopsy of Prostate, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, MRI Ultrasound Fusion Guided Biopsy

Location

USC / Norris Comprehensive Cancer Center
Los Angeles
California
United States
90033

Status

Not yet recruiting

Source

University of Southern California

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-08-01T13:38:21-0400

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