Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer

PRIMARY OBJECTIVES:

I. To improve the treatment of patients with prostate cancer utilizing diagnostic
multi-parametric magnetic resonance imaging (MRI) and MRI-guided prostate biopsy combined
with molecular and clinical data to help determine the extent of prostate cancer and risk of
disease progression.

II. To determine the relative accuracy of transrectal MRI-guided versus ultrasound-guided
biopsy for the diagnosis of prostate cancer in patients with an appropriate dominant target
lesion at multiparametric MRI, using pooled cancer diagnoses by either MRI-guided or
ultrasound-guided biopsy as the reference standard.

III. To determine the proportion of positive transrectal MRI-guided biopsies that demonstrate
a higher Gleason score than contemporaneous transrectal ultrasound guided biopsy.

IV. To determine the management impact of transrectal MRI-targeted biopsy results as compared
to transrectal ultrasound (TRUS)-guided systematic biopsy results.

OUTLINE:

Patients receive gadodiamide intravenously (IV) and undergo a diagnostic multiparametric
endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal
MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric
endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care
approximately 2 weeks after transrectal MRI-guided biopsy.

Inclusion Criteria:

- Scheduled TRUS-guided biopsy because of clinically suspected prostate cancer (abnormal
serum prostate-specific antigen [PSA] level and/or abnormal digital rectal
examination)

- No treatment for prostate cancer has been administered or will be administered before
TRUS guided biopsy

- Patient willing to undergo scheduled standard of care TRUS guided biopsy

- Patient willing and able to provide written informed consent, including willingness to
undergo both endorectal multiparametric MRI and transrectal MRI-guided biopsy at
Oregon Health & Science University (OHSU)

- Laboratory values and anticoagulation management per consensus guidelines, including:

- International normalized ratio (INR) >= 1.5

- Platelets >= 50,000

Exclusion Criteria:

- Known contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm
clips, intraocular metallic foreign body, cardiac pacemaker); an extensive screening
questionnaire will be completed by the subject as part of standard OHSU MRI safety
measures

- Known contraindication to intravenous gadolinium contrast administration (e.g., renal
impairment, known allergy); standard institutional policies on gadolinium and renal
function will be followed

- Contraindication to placement of endorectal MRI coil, biopsy device or ultrasound
probe (e.g., severe hemorrhoids, anal fissure, recent rectal surgery, or prior
abdominoperineal resection)

- Previous inclusion in the study (e.g., a patient who has had negative TRUS and
MRI-guided biopsies but continues to have a rising PSA)

- Active urinary tract infection

- Member of vulnerable population including prisoners or mentally disabled patients, in
accordance with U.S. Department of Health and Human Services (DHHS) definitions