NCT06986083

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_3 prostate-cancer

Timeline
24mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
May 2025May 2028

Study Start

First participant enrolled

May 19, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

May 20, 2025

Last Update Submit

July 31, 2025

Conditions

Prostate Cancer

Keywords

Needle-Based ProceduresIV sedationLocal anesthesia25-085

Outcome Measures

Primary Outcomes (1)

  • Change in the proportion of patients experiencing significant pain

    defined as at least one pain score ≥ 5 on a 0 - 10 scale in the post anesthesia care unit (PACU)

    up to 1 day

Study Arms (2)

No Local anesthesia

EXPERIMENTAL

No local anesthesia during transperineal biopsy under IV sedation

Procedure: Prostate Biopsy

Local anesthesia

ACTIVE COMPARATOR

Local anesthesia during transperineal biopsy under IV sedation

Procedure: Prostate BiopsyDrug: Local anesthesia

Interventions

Prostate BiopsyPROCEDURE

Transperineal prostate biopsy

Local anesthesiaNo Local anesthesia
Local anesthesiaDRUG

Local anesthesia in addition to IV sedation

Local anesthesia

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Jonathan Fainberg, MD, MPH

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Fainberg, MD, MPH

CONTACT

646-422-4894fainberj@mskcc.org

Behrar Ehdaie, MD, MPH

CONTACT

646-422-4406

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: This is an ongoing, rolling phase III study. This is a surgical trial. Any agents administered to patients during the trial are part of routine care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 22, 2025

Study Start

May 19, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)