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

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.

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