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

NCT03632655 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-05-31

Study results available
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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.

Conditions

Interventions

PROCEDURE

prostate biopsy

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

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Jim Hu, M.D., M.P.H. · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-23
Primary Completion
2020-10-08
Completion
2020-10-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03632655 on ClinicalTrials.gov