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

• ClinicalTrials.gov Identifier: NCT03234556
• Recruitment Status: Recruiting
• First Posted: July 31, 2017
• Last Update Posted: August 9, 2022
• Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Southern California

Tracking Information

• First Submitted Date: July 26, 2017
• First Posted Date: July 31, 2017
• Last Update Posted Date: August 9, 2022
• Actual Study Start Date: September 25, 2017
• Estimated Primary Completion Date: September 25, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 18, 2018)

Biopsy detection rate of clinically significant prostate cancer [ Time Frame: Up to 5 years ]

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.

Original Primary Outcome Measures (submitted: July 26, 2017)

Biopsy detection rate of clinically significant prostate cancer [ Time Frame: Up to 5 years ]

In Arm 1, 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. In Arm 2, will code patients as having clinically significant prostate cancer if they are diagnosed with an magnetic resonance imaging with prostate imaging-reporting and data system >= 3 and are diagnosed with Gleason score >= 7 or any Gleason score with core length >= 5 mm or any Gleason score that includes Gleason pattern >= 4 after

Current Secondary Outcome Measures (submitted: January 18, 2018)

Presence of any of the complications [ Time Frame: Up to 5 years ]

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.

Original Secondary Outcome Measures (submitted: July 26, 2017)

Presence of any of the complications [ Time Frame: Up to 5 years ]

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.

Current Other Pre-specified Outcome Measures (submitted: January 18, 2018)

Highest Gleason score [ Time Frame: Up to 5 years ]

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.

Original Other Pre-specified Outcome Measures (submitted: July 26, 2017)

Highest Gleason score [ Time Frame: Up to 5 years ]

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.

Descriptive Information

• Brief Title: Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
• 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
• Brief 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Health Status Unknown
• Elevated PSA

Intervention

• Procedure: Biopsy of Prostate
  Undergo SR-Bx
  Other Names:

  • Prostate Biopsy
  • Prostatic Biopsy
• Other: Laboratory Biomarker Analysis
  Correlative studies
• Diagnostic Test: Magnetic Resonance Imaging
  Undergo MRI
  Other Names:

  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
• Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy
  Undergo MRUS-Bx
  Other Names:

  • Fusion Biopsy
  • Fusion-Guided Biopsy
  • MR Fusion Biopsy
  • MRI-Ultrasound Fusion Biopsy
  • MRI/Ultrasound Fusion Biopsy
  • MRI/US Biopsy

Study Arms

• Active Comparator: 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.
  Interventions:

  • Procedure: Biopsy of Prostate
  • Other: Laboratory Biomarker Analysis
  • Diagnostic Test: Magnetic Resonance Imaging
  • Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy
• Experimental: 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.
  Interventions:

  • Procedure: Biopsy of Prostate
  • Other: Laboratory Biomarker Analysis
  • Diagnostic Test: Magnetic Resonance Imaging
  • Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 26, 2017): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 25, 2025
• Estimated Primary Completion Date: September 25, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ileana Aldana; 323-865-0702; Ileana.aldana@med.usc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03234556
• Other Study ID Numbers: 4P-16-7; NCI-2017-00890 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 4P-16-7 ( Other Identifier: USC / Norris Comprehensive Cancer Center ); P30CA014089 ( U.S. NIH Grant/Contract ); R01CA205058 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Southern California
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Southern California
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Inderbir Gill; University of Southern California

• PRS Account: University of Southern California
• Verification Date: August 2022