Using local anesthesia during prostate biopsies to reduce pain
A Randomized Controlled Trial of Modifications to Prostate Needle-Based Procedures
PHASE3 · Memorial Sloan Kettering Cancer Center · NCT06986083
This study tests whether using local anesthesia with IV sedation during prostate biopsies can help reduce pain and improve recovery for patients.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06986083 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of local anesthesia combined with IV sedation during transperineal prostate biopsies to minimize pain experienced by patients in the recovery room. Researchers will assess the impact of local anesthesia on pain medication usage, recovery time, and overall patient outcomes post-biopsy. The study aims to standardize care pathways for patients undergoing prostate procedures at Memorial Sloan Kettering Cancer Center.
Who should consider this trial
Good fit: Ideal candidates include men scheduled for transperineal prostate biopsies or partial prostate gland ablation procedures at the JRSC.
Not a fit: Patients who are not undergoing prostate biopsies or ablation procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve recovery experiences for patients undergoing prostate biopsies.
How similar studies have performed: Other studies have shown promising results with similar approaches to pain management during prostate procedures.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Jonathan Fainberg, MD, MPH — Memorial Sloan Kettering Cancer Center
- Study coordinator: Jonathan Fainberg, MD, MPH
- Email: fainberj@mskcc.org
- Phone: 646-422-4894
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Needle-Based Procedures, IV sedation, Local anesthesia, 25-085