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

NCT03632655 | Terminated Results FDA Device

• 1 other identifier: 1705018187
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Elevated PSA

Outcome Measures

Primary Outcomes (1)

• Gleason Grade

  Detection of clinically significant disease Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. * Scores of 6 or less describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly. * A score of 7 suggests and intermediate risk for aggressive cancer. Scoring a 7 means that the primary score (largest section of the tumor) scored a 3 or 4. Tumors with a primary score of 3 and a secondary score of 4 have a fairly good outlook, whereas cancers with a primary Gleason Score of 4 and a secondary score of 3, are more likely to grow and spread. * Scores of 8 or higher describe cancers that are likely to spread more rapidly, these cancers are often referred to as poorly differentiated or high grade.

  7 days post-biopsy

Secondary Outcomes (5)

• Patient-reported Pain, as Measured on a 0-10 Likert Scale

  At time of local anesthesia administration, initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 3 months post-biopsy

• Patient-reported Symptoms, as Measured by International Prostate Symptom Scores (IPSS) Questionnaire

  baseline, 7 days post-biopsy, 30 days post-biopsy

• Patient-reported Erectile Function, as Measured by International Index of Erectile Function (IIEF-5) Questionnaire

  baseline, 7 days post-biopsy, 30 days post-biopsy

• Patient-reported Quality of Life, as Measured by EPIC-CP Questionnaire

  baseline, 7 days post-biopsy, 30 days post-biopsy

• Adverse Events

  initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 30 days post-biopsy

Study Arms (2)

Transrectal Ultrasound Guided Biopsy (TRUS)

ACTIVE COMPARATOR

Patients will receive a transrectal guided prostate biopsy

Procedure: prostate biopsy

Transperineal Prostate Biopsy

ACTIVE COMPARATOR

Patients will receive a transperineal prostate biopsy

Procedure: prostate biopsy

Interventions

prostate biopsy PROCEDURE

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

Transperineal Prostate Biopsy; Transrectal Ultrasound Guided Biopsy (TRUS)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must have clinical suspicion of prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Early termination due to procurement of new funding sources.

Results Point of Contact

• Title: Dr. Jim C. Hu
• Organization: Weill Cornell Medicine

jch9011@med.cornell.edu

(646) 962-9600

Study Officials

• Jim Hu, M.D., M.P.H.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Men will be randomized to receiving either TPM or TRUS targeted biopsy.

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 15, 2018
• Study Start: December 23, 2017
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: May 31, 2024
• Results First Posted: July 13, 2021

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)