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

Health Status Unknown Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03234556
• Other study ID #: 4P-16-7
• Secondary ID: NCI-2017-008904P
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: September 25, 2026

Study information

• Verified date: April 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 288
• Est. completion date: September 25, 2026
• Est. primary completion date: September 25, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elevated PSA
• Health Status Unknown
• Prostatic Neoplasms

Intervention

Procedure:
• Biopsy of Prostate
Undergo SR-Bx

Other:
• Laboratory Biomarker Analysis
Correlative studies

Diagnostic Test:
• Magnetic Resonance Imaging
Undergo MRI
• MRI Ultrasound Fusion Guided Biopsy
Undergo MRUS-Bx

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Henry Ford Hospital Vattikuti Urology Institute	Detroit	Michigan
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Highest Gleason score	Will assess the highest Gleason score in magnetic resonance imaging-ultrasound image fusion biopsy and systematic random biopsy. Will evaluated using agreement metrics such as percent agreement, Cohen's kappa (k) statistic and Krippendorff's alpha statistic. Significance will be considered if p < 0.05.	Up to 5 years
Primary	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	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