A Study of Changes to Prostate Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prostate Biopsy, Local anesthesia.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Trial of Modifications to Prostate Needle-Based Procedures
Overview
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
- Procedure Prostate Biopsy
Transperineal prostate biopsy - Drug Local anesthesia
Local anesthesia in addition to IV sedation
Primary outcome measures
- Change in the proportion of patients experiencing significant pain [Time frame: up to 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale
- Memorial Sloan Kettering Suffolk-Commack (Consent only) — Commack
- Memorial Sloan Kettering Westchester (Consent Only) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (Consent Only) — Uniondale
Identifiers
NCT: NCT06986083 · 25-085