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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Health Status Unknown, Elevated PSA

Intervention / Treatment
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* Procedure: Biopsy of Prostate
* Other: Laboratory Biomarker Analysis
* Diagnostic Test: Magnetic Resonance Imaging
* Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information Note: HIPAA authorization may be included in the informed consent or obtained separately Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 3 months (93 days) prior to being registered for protocol African-American or white men (Hispanic or non-Hispanic) Prostate biopsy-naive or a single negative biopsy Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE) Ability to understand the willingness to sign a written informed consent Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate Patients must be willing to undergo a biopsy of the prostate Exclusion Criteria: Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer Patients receiving any other investigational agents Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients with active inflammatory bowel disease Patients who are unable to undergo MRI Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate) Patients who had > 1 prior prostate biopsy

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (SR-Bx)<br>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. | Procedure: Biopsy of Prostate<br>* Undergo SR-Bx<br>* Other names: Prostatic Biopsy;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Diagnostic Test: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy<br>* Undergo MRUS-Bx<br>* Other names: MRI/US Biopsy;|
| Experimental: Arm II (MRI, MRUS-Bx, SR-Bx)<br>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. | Procedure: Biopsy of Prostate<br>* Undergo SR-Bx<br>* Other names: Prostatic Biopsy;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Diagnostic Test: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: Nuclear Magnetic Resonance Imaging;Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy<br>* Undergo MRUS-Bx<br>* Other names: MRI/US Biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy detection rate of clinically significant prostate cancer | Will code patients as having clinically significant prostate cancer if they are diagnosed with Gleason score >= 7 or any Gleason score with core length >= 5 mm or any Gleason score that includes Gleason pattern >= 4 at initial systematic random biopsy. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of any of the complications | Will be summarized in the complications checklist. Will determine any striking co-morbidities that are present post-biopsy and were absent pre-biopsy within each arm, and next determine if the prevalence of any of these identified post-biopsy morbidities differs between the two arms. For these analyses, regression methods (linear, logistic, multinomial logistic as appropriate for the dependent variable being analyzed) will be used. Standard descriptive methods will be used to summarize and display the results. | Up to 5 years |