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NCT Number: NCT06986083

A Study of Changes to Prostate Procedures

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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostate biopsy

Procedure

Transperineal prostate biopsy

Local anesthesia

Drug

Local anesthesia in addition to IV sedation

Primary outcomes

  1. Change in the proportion of patients experiencing significant pain

    Time frame: up to 1 day

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

Study contacts

Contact information is provided by the study sponsor or research team.

Behrar Ehdaie, MD, MPH

CONTACT

646-422-4406

Jonathan Fainberg, MD, MPH

CONTACT

[email protected]

646-422-4894

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 22, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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