A Study of Changes to Prostate Procedures

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06986083
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prostate Biopsy — PROCEDURE
    Transperineal prostate biopsy
  • Local anesthesia — DRUG
    Local anesthesia in addition to IV sedation

Study Details

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.

Key Dates

Start date
May 19, 2025
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: No Local anesthesia
    No local anesthesia during transperineal biopsy under IV sedation
  • Active Comparator: Local anesthesia
    Local anesthesia during transperineal biopsy under IV sedation

Primary Outcome Measure

Change in the proportion of patients experiencing significant pain [ Time Frame: up to 1 day ]

Central Contacts

  • Jonathan Fainberg, MD, MPH
    646-422-4894
    [email protected]
  • Behrar Ehdaie, MD, MPH
    646-422-4406

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only)Basking RidgeNew Jersey07920
Jonathan Fainberg, MD, MPH
646-422-4894
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Jonathan Fainberg, MD, MPH
646-422-4894
Memorial Sloan Kettering Bergen (Consent Only)MontvaleNew Jersey07645
Jonathan Fainberg, MD, MPH
646-422-4894
Memorial Sloan Kettering Suffolk-Commack (Consent only)CommackNew York11725
Jonathan Fainberg, MD, MPH
646-422-4894
Memorial Sloan Kettering Westchester (Consent Only)HarrisonNew York10604
Jonathan Fainberg, MD, MPH
646-422-4894
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Jonathan Fainberg, MD, MPH
646-422-4894
Behfar Ehdaie, MD, MPH
646-422-4406
Jonathan Fainberg, MD, MPH (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Consent Only)UniondaleNew York11553
Jonathan Fainberg, MD, MPH
646-422-4894

Find similar trials in Basking Ridge, NJ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Consent Only)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Consent only)· Commack, NYMemorial Sloan Kettering Westchester (Consent Only)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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