Recruiting
Phase 3

Local Anesthesia

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06986083

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prostate Biopsy

Local anesthesia

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT06986083

Start date

May 19, 2025

Status verified date

May, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: No Local anesthesia

No local anesthesia during transperineal biopsy under IV sedation

active comparator: Local anesthesia

Local anesthesia during transperineal biopsy under IV sedation

Interventions

Prostate Biopsy

Transperineal prostate biopsy

Local anesthesia

Local anesthesia in addition to IV sedation

Primary outcome measure

  • Change in the proportion of patients experiencing significant pain [ Time Frame: up to 1 day ]

Central Contacts and Locations

Central contacts

Jonathan Fainberg, MD, MPH

646-422-4894fainberj@mskcc.org

Behrar Ehdaie, MD, MPH

646-422-4406

Locations

Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Jonathan Fainberg, MD, MPH

646-422-4894

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Jonathan Fainberg, MD, MPH

646-422-4894

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Jonathan Fainberg, MD, MPH

646-422-4894

Memorial Sloan Kettering Suffolk-Commack (Consent only)

Recruiting

Commack, New York, United States, 11725

Contacts

Jonathan Fainberg, MD, MPH

646-422-4894

Memorial Sloan Kettering Westchester (Consent Only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Jonathan Fainberg, MD, MPH

646-422-4894

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Jonathan Fainberg, MD, MPH

646-422-4894

Behfar Ehdaie, MD, MPH

646-422-4406

Principal Investigator:

Jonathan Fainberg, MD, MPH

Memorial Sloan Kettering Nassau (Consent Only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Jonathan Fainberg, MD, MPH

646-422-4894

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-22.