Clinical trial NCT03234556: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health Status Unknown
Elevated PSA
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-07-31
Enrollment: 288
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Biopsy detection rate of clinically significant prostate cancer
timeFrame: Up to 5 years
Secondary outcomes:
measure: Presence of any of the complications
timeFrame: Up to 5 years
Other outcomes:
measure: Highest Gleason score
timeFrame: Up to 5 years
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital Vattikuti Urology Institute
state: Michigan
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: University of Southern California
name: Inderbir Gill
role: PRINCIPAL_INVESTIGATOR
References: