A Study of Changes to Prostate Procedures
Status
RECRUITING
Phase
PHASE3
Age
≥ 18 Years
Enrollments
800Conditions
Prostate CancerDrugs
Local anesthesiaSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Jonathan Fainberg, MD, MPH
- 646-422-4894
Principal Investigator
- Jonathan Fainberg, MD, MPH
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
Study Plan
No Local anesthesia
EXPERIMENTAL
No local anesthesia during transperineal biopsy under IV sedation
PROCEDURE:
Prostate BiopsyDescription:
Transperineal prostate biopsy
Local anesthesia
ACTIVE_COMPARATOR
Local anesthesia during transperineal biopsy under IV sedation
PROCEDURE:
Prostate BiopsyDescription:
Transperineal prostate biopsyDRUG:
Local anesthesiaDescription:
Local anesthesia in addition to IV sedation
Outcome Measures
Primary Outcome Measures
Change in the proportion of patients experiencing significant pain
Timeline
Last Updated
August 5, 2025Start Date
May 22, 2025Today
October 16, 2025Completion Date ( Estimated )
May 1, 2028
Sponsors of this trial
Lead Sponsor
Memorial Sloan Kettering Cancer Center
RECRUITING 
≥ 18 Years