Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Local anesthesia | Experimental | No local anesthesia during transperineal biopsy under IV sedation |
|
| Local anesthesia | Active Comparator | Local anesthesia during transperineal biopsy under IV sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate Biopsy | Procedure | Transperineal prostate biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the proportion of patients experiencing significant pain | defined as at least one pain score ≥ 5 on a 0 - 10 scale in the post anesthesia care unit (PACU) | up to 1 day |
Not provided
Not provided
Inclusion Criteria:
Local anesthesia versus no local anesthesia during transperineal biopsy, while the patient is under IV sedation:
Standardization of a periprocedural pathway versus usual care for focal gland ablation:
Exclusion Criteria:
Local anesthesia versus no local anesthesia during transperineal biopsy, while patient is under IV sedation:
Standardization of a periprocedural pathway versus usual care for focal gland ablation:
Prostate Cancer
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Fainberg, MD, MPH | Contact | 646-422-4894 | fainberj@mskcc.org | |
| Behrar Ehdaie, MD, MPH | Contact | 646-422-4406 |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Fainberg, MD, MPH | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided
This is an ongoing, rolling phase III study. This is a surgical trial. Any agents administered to patients during the trial are part of routine care.
Not provided
Not provided
Not provided
Not provided
| Local anesthesia | Drug | Local anesthesia in addition to IV sedation |
|
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Consent Only) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk-Commack (Consent only) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Consent Only) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (Consent Only) | Recruiting | Uniondale | New York | 11553 | United States |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |