A Study of Changes to Prostate Procedures

May 19, 2026 updated by: Memorial Sloan Kettering Cancer Center

A Randomized Controlled Trial of Modifications to Prostate Needle-Based Procedures

The purpose of this study is to look whether using local anesthesia during a transperineal prostate biopsy, while put to sleep by IV sedation, helps reduce the number of people who feel significant pain in the recovery room. The researchers will also look at how local anesthesia affects the amount of pain medication used, how quickly people can go home after the biopsy, and how well they recover after leaving the hospital.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Behrar Ehdaie, MD, MPH
  • Phone Number: 646-422-4406

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only)
        • Contact:
          • Jonathan Fainberg, MD, MPH
          • Phone Number: 646-422-4894
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited protocol activities)
        • Contact:
          • Jonathan Fainberg, MD, MPH
          • Phone Number: 646-422-4894
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Consent Only)
        • Contact:
          • Jonathan Fainberg, MD, MPH
          • Phone Number: 646-422-4894
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk-Commack (Consent only)
        • Contact:
          • Jonathan Fainberg, MD, MPH
          • Phone Number: 646-422-4894
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Consent Only)
        • Contact:
          • Jonathan Fainberg, MD, MPH
          • Phone Number: 646-422-4894
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Behfar Ehdaie, MD, MPH
          • Phone Number: 646-422-4406
        • Contact:
          • Jonathan Fainberg, MD, MPH
          • Phone Number: 646-422-4894
        • Principal Investigator:
          • Jonathan Fainberg, MD, MPH
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Consent Only)
        • Contact:
          • Jonathan Fainberg, MD, MPH
          • Phone Number: 646-422-4894

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Local anesthesia versus no local anesthesia during transperineal biopsy, while the patient is under IV sedation:

  • Patients scheduled for transperineal prostate biopsy at the JRSC or Monmouth.

Standardization of a periprocedural pathway versus usual care for focal gland ablation:

  • Patients scheduled for a partial prostate gland ablation procedure at the JRSC.

Exclusion Criteria:

Local anesthesia versus no local anesthesia during transperineal biopsy, while patient is under IV sedation:

  • None

Standardization of a periprocedural pathway versus usual care for focal gland ablation:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No Local anesthesia
No local anesthesia during transperineal biopsy under IV sedation
Procedure: Prostate Biopsy
Transperineal prostate biopsy
Active Comparator: Local anesthesia
Local anesthesia during transperineal biopsy under IV sedation
Procedure: Prostate Biopsy
Transperineal prostate biopsy
Drug: Local anesthesia
Local anesthesia in addition to IV sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the proportion of patients experiencing significant pain
Time Frame: up to 1 day
defined as at least one pain score ≥ 5 on a 0 - 10 scale in the post anesthesia care unit (PACU)
up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Jonathan Fainberg, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

May 20, 2025

First Submitted That Met QC Criteria

May 20, 2025

First Posted (Actual)

May 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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