A Study of Changes to Prostate Procedures

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 3

Conditions: Prostate Cancer

Treatments: Procedure: Prostate Biopsy; Drug: Local anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06986083

25-085

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

No Local anesthesia

Experimental group

Description:

No local anesthesia during transperineal biopsy under IV sedation

Treatment:

Procedure: Prostate Biopsy

Local anesthesia

Active Comparator group

Description:

Local anesthesia during transperineal biopsy under IV sedation

Treatment:

Drug: Local anesthesia

Procedure: Prostate Biopsy