Prostate CancerPhase 3NCT06986083
A Study of Changes to Prostate Procedures
A Phase 3 study testing Prostate Biopsy and Local anesthesia in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate Biopsy and Local anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 May 2025to May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Behrar Ehdaie, MD, MPH contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Jonathan Fainberg, MD, MPH, 646-422-4894
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Consent only)
Commack, New York, 11725
Jonathan Fainberg, MD, MPH, 646-422-4894
- Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Jonathan Fainberg, MD, MPH, 646-422-4894
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Jonathan Fainberg, MD, MPH, 646-422-4894
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Jonathan Fainberg, MD, MPH, 646-422-4894
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Jonathan Fainberg, MD, MPH, 646-422-4894
Behfar Ehdaie, MD, MPH, 646-422-4406
- Recruiting
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553
Jonathan Fainberg, MD, MPH, 646-422-4894
About this study
Official title: A Randomized Controlled Trial of Modifications to Prostate Needle-Based Procedures
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.
- Conditions
- Prostate Cancer
- Being tested
- Prostate Biopsy, Local anesthesia
- Keywords
- Needle-Based Procedures, IV sedation, Local anesthesia, 25-085
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate BiopsyProcedure or surgery
Transperineal prostate biopsy
Local anesthesiaDrug
Local anesthesia in addition to IV sedation
| Study group | Role | What they receive |
|---|---|---|
| No Local anesthesia | Experimental | No local anesthesia during transperineal biopsy under IV sedation Receives: Procedure: Prostate Biopsy |
| Local anesthesia | Active comparator | Local anesthesia during transperineal biopsy under IV sedation Receives: Procedure: Prostate Biopsy; Drug: Local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start19 May 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Fainberg, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986083
- Sponsor's protocol ID
- 25-085
- Status last verified
- Sep 2026
- First submitted
- 20 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Modifications to Prostate Needle-Based Procedures
- ClinicalTrials.gov ID
- NCT06986083
- Acronym / sponsor ID
- 25-085
- Conditions
- Prostate Cancer
- Keywords
- Needle-Based Procedures, IV sedation, Local anesthesia, 25-085
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| No Local anesthesia | Experimental | Procedure: Prostate BiopsyNo local anesthesia during transperineal biopsy under IV sedation |
| Local anesthesia | Active comparator | Procedure: Prostate Biopsy, Drug: Local anesthesiaLocal anesthesia during transperineal biopsy under IV sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Patients scheduled for a partial prostate gland ablation procedure at the JRSC.
Key exclusion criteria (4 listed)
- Local anesthesia versus no local anesthesia during transperineal biopsy, while patient is under IV sedation:
- None
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate BiopsyTransperineal prostate biopsy | Procedure or surgery | Local anesthesia, No Local anesthesia |
| Local anesthesiaLocal anesthesia in addition to IV sedation | Drug | Local anesthesia |
Primary outcome
Change in the proportion of patients experiencing significant pain
Time frame: up to 1 day
defined as at least one pain score ≥ 5 on a 0 - 10 scale in the post anesthesia care unit (PACU)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Behrar Ehdaie, MD, MPH contact
Jonathan Fainberg, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prostate Biopsy and Local anesthesia in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Fainberg, MD, MPH (646-422-4894, fainberj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the proportion of patients experiencing significant pain (time frame: up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.