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

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ClinicalTrials.gov Identifier: NCT03234556
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Health Status Unknown Elevated PSA Procedure: Biopsy of Prostate Other: Laboratory Biomarker Analysis Diagnostic Test: Magnetic Resonance Imaging Diagnostic Test: MRI Ultrasound Fusion Guided Biopsy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : September 25, 2020
Estimated Study Completion Date : September 25, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234556


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

Locations
United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Ileana Aldana    323-865-0702    Ileana.aldana@med.usc.edu   
Principal Investigator: Inderbir Gill, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Ganine Markowitz-Chrystal    410-328-0800    gmarkowitz@som.umaryland.edu   
Principal Investigator: Minhaj Siddiqui, MD         
Johns Hopkins University/Sidney Kimmel Cancer Center Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Inderbir Gill    323-865-3000      
Principal Investigator: Inderbir Gill         
Chesapeake Urology Associates Not yet recruiting
Towson, Maryland, United States, 21204
Contact: Inderbir Gill    323-865-3000      
Principal Investigator: Inderbir Gill         
United States, Michigan
Henry Ford Hospital Vattikuti Urology Institute Recruiting
Detroit, Michigan, United States, 48202
Contact: Ali A. Dabaja, MD    313-717-8680    adabaja2@hfhs.org   
Contact: Mustafa Deebajah    313-717-8680    Mdeebaj1@hfhs.org   
Principal Investigator: James Peabody, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jonathan Coleman, MD    646-422-4432    colemanj@mskcc.org   
Principal Investigator: Jonathan Coleman, MD         
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Inderbir Gill    323-865-3000      
Principal Investigator: Inderbir Gill         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Inderbir Gill University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03234556     History of Changes
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 )
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases