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