Local Anesthesia for Prostate Cancer

Overseen By Jonathan Fainberg, MD, MPH

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether local anesthesia (a medication that numbs a specific area of the body) can reduce pain during recovery after a prostate biopsy. The study compares two groups: one receives local anesthesia, and the other does not, while both are under IV sedation during the procedure. Researchers are also examining whether local anesthesia affects the need for pain medication, the time until discharge, and overall recovery. This trial may suit those scheduled for a prostate biopsy at JRSC or Monmouth. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to important research on pain management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using local anesthesia during a transperineal prostate biopsy is safe and generally well-received by patients. Studies have found that most patients handle this method well and do not experience major side effects. For instance, one study found that the procedure is not only safe but can also be done easily during a regular doctor's visit. Another study confirmed these results, noting patient satisfaction with the process. Overall, evidence supports the safety of using local anesthesia in these biopsies, indicating it is a dependable way to reduce discomfort. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about exploring the use of local anesthesia for prostate cancer biopsies because it could offer a more comfortable and less painful experience compared to the standard approach. Typically, prostate biopsies are performed under IV sedation, which can leave patients feeling groggy and uncomfortable. However, local anesthesia targets pain specifically at the biopsy site, potentially reducing the overall sedation required. This approach could not only improve patient comfort but also decrease recovery time and associated sedation risks.

What evidence suggests that local anesthesia is effective for reducing pain during prostate cancer biopsies?

This trial will compare local anesthesia to no local anesthesia during transperineal biopsy under IV sedation. Studies have shown that local anesthesia for prostate biopsies is effective. Research indicates it is safe and well-tolerated, with many patients finding it acceptable. Patients often report less pain and discomfort with local anesthesia. It can also reduce the need for extra pain medication and aid in faster recovery after the procedure. Overall, local anesthesia can make prostate biopsies easier and more comfortable for patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Jonathan Fainberg, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with prostate cancer who are scheduled to undergo a transperineal prostate biopsy. Participants should be suitable for IV sedation and local anesthesia during the procedure.

Inclusion Criteria

I am scheduled for a prostate biopsy with or without local anesthesia.

I am scheduled for a partial prostate gland removal.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a transperineal prostate biopsy with or without local anesthesia under IV sedation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and recovery in the post anesthesia care unit

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Local anesthesia

Trial Overview The study is testing if using local anesthesia in addition to IV sedation during a prostate biopsy can reduce pain post-procedure, decrease pain medication use, speed up discharge times, and improve recovery after leaving the hospital.

How Is the Trial Designed?

Group I: No Local anesthesia Experimental Treatment 1 Intervention

No local anesthesia during transperineal biopsy under IV sedation

Group II: Local anesthesia Active Control 2 Interventions

Local anesthesia during transperineal biopsy under IV sedation

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40566122/

Transperineal Prostate Biopsy Under Local Anaesthesia, ... Overall patient tolerability was high. Local anaesthesia provided procedural flexibility, reduced resource utilisation, was cost-effective, and ...

2. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00100-7/fulltext

Local anaesthetic transperineal biopsy versus transrectal ... We found GGG 2 or higher prostate cancer in 329 (60%) of 547 participants with biopsy results randomly assigned to LATP compared with 294 (54%) ...

3. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.16722

Transperineal prostate biopsy under local vs general ... Overall, LA TPB has been demonstrated to be a safe and well tolerated method of prostate sampling, with a very low incidence of urinary tract ...

4. icurology.org icurology.org/DOIx.php?id=10.4111/icu.20250077

:: ICU :: Investigative and Clinical Urology This study aims to evaluate patient experience and feedback about the transperineal prostate biopsy under LA using the PPTAS by using patient-reported outcome ...

5. cureus.com cureus.com/articles/399678-from-theater-to-clinic-a-retrospective-evaluation-of-local-anesthetic-transperineal-biopsy-for-the-rapid-diagnosis-of-prostate-cancer

From Theater to Clinic: A Retrospective Evaluation of Local ... Patient tolerability of TP biopsy under local anesthesia has been shown to be acceptable in most cases. Many patients report that the experience ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41089160/

From Theater to Clinic: A Retrospective Evaluation of Local ... The mean satisfaction score with the diagnostic process was 8.2/10. Among surveyed patients, 68% indicated they would choose the same local ...

7. goldjournal.net goldjournal.net/article/S0090-4295(23)00803-8/abstract

Patient Reported Outcomes of Transperineal Prostate ... Transperineal biopsy using local tumescent anesthesia is safe and well-tolerated. Despite the benefits, patients undergoing a transperineal prostate biopsy ...

8. med.virginia.edu med.virginia.edu/urology/wp-content/uploads/sites/248/2021/11/Stefanova-et-al-J-Urol-2019.pdf

Transperineal Prostate Biopsies Using Local Anesthesia Results: The cancer detection rate of transperineal prostate biopsy was 49.8%. (641 of 1,287 patients). Clinically significant prostate cancer was detected in ...