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RecruitingInterventionalPhase 3

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

NCT ID: NCT06986083Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-05-22

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.

Arms & interventions

  • ProcedureProstate Biopsy

    Transperineal prostate biopsy

  • DrugLocal anesthesia

    Local anesthesia in addition to IV sedation

Outcome measures

Primary

  • 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)

    Time frame: up to 1 day

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (7)

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

Basking Ridge, New Jersey, 07920

Recruiting
Jonathan Fainberg, MD, MPH · Contact
646-422-4894

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Jonathan Fainberg, MD, MPH · Contact
646-422-4894

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, 07645

Recruiting
Jonathan Fainberg, MD, MPH · Contact
646-422-4894

Memorial Sloan Kettering Suffolk-Commack (Consent only)

Commack, New York, 11725

Recruiting
Jonathan Fainberg, MD, MPH · Contact
646-422-4894

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, 10604

Recruiting
Jonathan Fainberg, MD, MPH · Contact
646-422-4894

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
Jonathan Fainberg, MD, MPH · Contact
646-422-4894
Behfar Ehdaie, MD, MPH · Contact
646-422-4406
Jonathan Fainberg, MD, MPH · Principal Investigator

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, 11553

Recruiting
Jonathan Fainberg, MD, MPH · Contact
646-422-4894