A Phase 1/2 interventional study of Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio) and Lidocaine in Prostate Cancer, sponsored by University of Washington. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by University of Washington · Phase 1/2, Interventional, and Supportive care
This phase I/II trial examines if buffered lidocaine reduces the pain that patients may experience during prostate biopsy. Prostate biopsies are typically performed awake, in the office, with only local anesthetic. As a result, many patients note considerable pain during these procedures. Local anesthetics such as lidocaine are typically acidic, which is thought to cause pain and burning during infiltration (injection). As a result, buffered local anesthetic has become the standard of care (SOC) in multiple specialties using awake local anesthetic. However, it has not been explored during prostate biopsies. Adminstering buffered lidocaine may reduce pain in patients undergoing prostate biopsy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
ARM B: Patients receive buffered lidocaine via injection during SOC prostate biopsy on study.
After completion of study intervention, patients are followed up 1-2 days post-biopsy.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 350 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Recommended to undergo a prostate biopsy in the urology clinic. Only patients that have been scheduled for a biopsy (for clinical purposes) will be enrolled. May include all of the following types of prostate biopsies:
Exclusion Criteria:
Patients receive SOC lidocaine via injection during SOC prostate biopsy on study.
Drug: Lidocaine · Procedure: Biopsy of Prostate · Other: Questionnaire Administration
Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)
Drug: Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio) · Procedure: Biopsy of Prostate · Other: Questionnaire Administration
Given via injection
Given via injection
Undergo SOC prostate biopsy
Also known as: Prostate Biopsy
Ancillary studies
Pain of Local Anesthetic Injection
Pain associated with the injection of local anesthetic, assessed by a written questionnaire (Visual Analogue Scale, 0 \[least\] to 10 \[worst pain\]).
Time frame: Within 20 seconds of completing the injection of all local anesthetic
Pain of the Prostate Biopsy
Pain associated with the biopsies of the prostate, assessed by a questionnaire (Visual Analogue Scale, 0 \[least\] to 10 \[worst pain\]).
Time frame: Within 10 minutes of completing the prostate biopsy, and on post-operative day 1
Willingness to perform another prostate biopsy in the future, if medically necessary
Assessed by a questionnaire (Visual Analogue Scale, 0 \[least likely\] to 10 \[most likely\])
Time frame: Within 10 minutes of completing the prostate biopsy, and on post-operative day 1
Incidence of adverse events
Will be assessed by patient self-report using an electronic written questionnaire. Will be assessed for inability to urinate, bleeding, allergic reaction, fever, or fatigue, or significant chills, or nausea/vomiting.
Time frame: Post-operative day 1
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Plan to share: No — This is a single center, investigator initiated trial.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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