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

Stopped early · Not applicable

Conditions studied: Health Status Unknown, Prostate Carcinoma

In brief

This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer. Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.

Key facts

Study ID

NCT02501759

Run by

OHSU Knight Cancer Institute

People needed

2

Starts

2015-05-01

Expected to finish

2017-02-10

Last updated by the study team

2019-04-03

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• OHSU Knight Cancer Institute — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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