A Study of Changes to Prostate Procedures

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06986083

Enrollment

800

Registered

2025-05-22

Start date

2025-05-19

Completion date

2028-05-01

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Needle-Based Procedures, IV sedation, Local anesthesia, 25-085

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.

Interventions

PROCEDUREProstate Biopsy

Transperineal prostate biopsy

DRUGLocal anesthesia

Local anesthesia in addition to IV sedation

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTJonathan Fainberg, MD, MPH

fainberj@mskcc.org646-422-4894

CONTACTBehrar Ehdaie, MD, MPH

646-422-4406

PRINCIPAL_INVESTIGATORJonathan Fainberg, MD, MPH

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026