Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
NCT ID: NCT03234556
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
288 participants
INTERVENTIONAL
2017-09-25
2028-05-23
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Arm I (SR-Bx)
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.
Biopsy of Prostate
Undergo SR-Bx
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo MRI
MRI Ultrasound Fusion Guided Biopsy
Undergo MRUS-Bx
Arm II (MRI, MRUS-Bx, SR-Bx)
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.
Biopsy of Prostate
Undergo SR-Bx
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo MRI
MRI Ultrasound Fusion Guided Biopsy
Undergo MRUS-Bx
Interventions
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Biopsy of Prostate
Undergo SR-Bx
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo MRI
MRI Ultrasound Fusion Guided Biopsy
Undergo MRUS-Bx
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Inderbir Gill
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Maryland
Baltimore, Maryland, United States
Henry Ford Hospital Vattikuti Urology Institute
Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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NCI-2017-00890
Identifier Type: REGISTRY
Identifier Source: secondary_id
4P-16-7
Identifier Type: OTHER
Identifier Source: secondary_id
4P-16-7
Identifier Type: -
Identifier Source: org_study_id