Local Anesthesia for Prostate Cancer

Overseen By Jonathan Fainberg, MD, MPH

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

800 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jonathan Fainberg, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for individuals with prostate cancer who are scheduled to undergo a transperineal prostate biopsy. Participants should be suitable for IV sedation and local anesthesia during the procedure.

Inclusion Criteria

I am scheduled for a prostate biopsy with or without local anesthesia.

I am scheduled for a partial prostate gland removal.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a transperineal prostate biopsy with or without local anesthesia under IV sedation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and recovery in the post anesthesia care unit

1 day

Treatment Details

Interventions

• Local anesthesia

Trial Overview The study is testing if using local anesthesia in addition to IV sedation during a prostate biopsy can reduce pain post-procedure, decrease pain medication use, speed up discharge times, and improve recovery after leaving the hospital.

Participant Groups

Group I: No Local anesthesia Experimental Treatment 1 Intervention

No local anesthesia during transperineal biopsy under IV sedation

Group II: Local anesthesia Active Control 2 Interventions

Local anesthesia during transperineal biopsy under IV sedation

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+