A Study of Changes to Prostate Procedures

Phase 3

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Prostate Biopsy; Drug: Local anesthesia

• Registration Number: NCT06986083
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-19
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Study First Posted: 2025-05-22
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-29
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 800

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.

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
No Local anesthesia	Prostate Biopsy	No local anesthesia during transperineal biopsy under IV sedation
Local anesthesia	Prostate Biopsy	Local anesthesia during transperineal biopsy under IV sedation
Local anesthesia	Local anesthesia	Local anesthesia during transperineal biopsy under IV sedation

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States