NCT02501759

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

Pilot Study of Transrectal Multiparametric MRI-Guided Biopsy: Role in Prostate Cancer Evaluation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Health Status Unknown
• Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	3 Tesla Magnetic Resonance Imaging	Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
RADIATION	Gadodiamide	Given IV
PROCEDURE	Multiparametric Magnetic Resonance Imaging	Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
PROCEDURE	Transrectal Biopsy	Undergo transrectal MRI-guided biopsy
PROCEDURE	Ultrasound-Guided Prostate Biopsy	Undergo TRUS-guided biopsy

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-12-31
• Completion: 2017-02-10
• First posted: 2015-07-17
• Last updated: 2019-04-03
• Results posted: 2019-04-03

Locations

1 site across 1 country: United States