A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches

NCT ID: NCT03632655

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-23
• Study Completion Date: 2020-10-08

Brief Summary

This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Primary endpoints will be pain as well as detection of clinically significant disease (defined as Gleason Score >=7 or cancer core length >=6 mm). Secondary endpoints will be detection of any prostate cancer, hospital re-admissions within 30 days, aborted procedures due to discomfort, procedure time, adverse events including hematuria, urinary retention, hematospermia, hematochezia, and infection, and patient-reported outcomes as measured on validated instruments such as International Prostate Symptom Scores (IPSS) and International Index of Erectile Function (IIEF-5). In men who subsequently elect to undergo radical prostatectomy for definitive treatment of their prostate cancer, Gleason scores at final pathology will be correlated to the Gleason scores obtained at time of biopsy.

Detailed Description

The feasibility of outpatient TPM has been well demonstrated.(Bianco & Martínez-Salamanca, 2016; Merrick et al., 2016; Smith et al., 2014) New technology now allows for fusion of MRI images with TPM devices, allowing for targeting of cancerous-appearing lesions on MRI. Such technology that fuses MRI-imaging with TRUS biopsy has become routine in U.S. clinical practice, with improved cancer detection rates as compared with standard TRUS.(Ahmed et al., 2017; Robertson, Emberton, & Moore, 2013)

This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Men will be randomized to receiving either TPM or TRUS targeted biopsy. All men will receive a urine culture within 2 weeks of biopsy and will be started on antibiotic prophylaxis prior to biopsy in accordance with AUA antimicrobial prophylaxis guidelines. Men with a positive urine culture will be treated with culture-specific antibiotics and must have a documented negative urine culture prior to biopsy.

Conditions

Prostate Cancer; Elevated PSA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Transrectal Ultrasound Guided Biopsy (TRUS)

Patients will receive a transrectal guided prostate biopsy

Group Type: ACTIVE_COMPARATOR

prostate biopsy

Intervention Type: PROCEDURE

Men will be randomized to receiving either TPM or TRUS targeted biopsy

Transperineal Prostate Biopsy

Patients will receive a transperineal prostate biopsy

Group Type: ACTIVE_COMPARATOR

prostate biopsy

Intervention Type: PROCEDURE

Men will be randomized to receiving either TPM or TRUS targeted biopsy

Interventions

prostate biopsy

Men will be randomized to receiving either TPM or TRUS targeted biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Men 18 years or older with suspicion for prostate cancer based upon an elevated PSA, abnormal digital rectal examination, abnormal MRI
• Men on active surveillance with indication for biopsy

Exclusion Criteria

• Men with active urinary tract infection, metastatic prostate cancer, history of colorectal surgery limiting insertion of transrectal probe, evidence of acute or chronic prostatitis, or concern for perineal cellulitis or fistula
• Men unfit to undergo prostate biopsy under local anesthesia
• Men with prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
• Men with contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jim Hu, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1705018187

Identifier Type: -

Identifier Source: org_study_id