Prostate CancerPhase 1/2BURNNCT06661902
Buffered Lidocaine for Reducing Pain in Patients Undergoing Prostate Biopsy, BURN Trial
A Phase 1/2 study testing Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio), Lidocaine and Biopsy of Prostate in people with Prostate Cancer, run by University of Washington at 1 site in United States.
Trial summary
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. 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?
- Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio), Lidocaine and Biopsy of Prostate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 27 Jan 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Provision of signed and dated informed consent form
- 18 years old or older
- Patients with prostates
- Those with and without a prior diagnosis of prostate cancer
- 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:
- Transperineal or transrectal
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- Systematic or targeted/fusion biopsy
- 12 core biopsy or > 12cores
- Biopsy naïve or prior biopsy
Who cannot join
- Anorectal pathology precluding placement of a transrectal ultrasound
- Diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome
- Concomitant chronic pain condition
- Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc.)
- Prostate biopsy performed with any anesthesia other than local anesthetic (monitored anesthesia care, general anesthesia)
- Prostate biopsy completed in the operating room
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- Patients who ultimately require additional local anesthetic beyond what is allotted in the study intervention
- Patients taking anxiolytics in the 6-hours prior to the biopsy
- Those with a known hypersensitivity, allergic reaction, or contraindication to using sodium bicarbonate. This includes patients who are receiving diuretics known to produce a hypochloremic alkalosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98195
About this study
Official title: BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio), Lidocaine, Biopsy of Prostate, Questionnaire Administration
- Keywords
- prostate cancer, prostate biopsy, transperineal biopsy, transrectal biopsy, MRI fusion biopsy, buffered lidocaine, sodium bicarbonate, Local anesthesia, lidocaine
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)Drug
Given via injection
LidocaineDrug
Given via injection
Biopsy of ProstateProcedure or surgery
Also called Prostate Biopsy
Undergo SOC prostate biopsy
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (lidocaine) | Active comparator | Patients receive SOC lidocaine via injection during SOC prostate biopsy on study. Receives: Drug: Lidocaine; Procedure: Biopsy of Prostate; Other: Questionnaire Administration |
| Arm B (buffered lidocaine) | Experimental | Patients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio) Receives: Drug: Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio); Procedure: Biopsy of Prostate; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: Within 20 seconds of completing the injection of all local anesthetic
Secondary outcomes (3)
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]).
Measured: 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])
Measured: 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.
Measured: Post-operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start9 Jan 2025
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
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 University of WashingtonThe 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Zhu, DO, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661902
- Sponsor's protocol ID
- RG1125023
- Other IDs
- STUDY00021446, NCI-2024-10011
- Acronym
- BURN
- Status last verified
- Feb 2026
- First submitted
- 25 Oct 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single center, investigator initiated trial.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy
- ClinicalTrials.gov ID
- NCT06661902
- Acronym / sponsor ID
- BURN / RG1125023
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate biopsy, transperineal biopsy, transrectal biopsy, MRI fusion biopsy, buffered lidocaine, sodium bicarbonate, Local anesthesia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 28 Oct 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (lidocaine) | Active comparator | Drug: Lidocaine, Procedure: Biopsy of Prostate, Other: Questionnaire AdministrationPatients receive SOC lidocaine via injection during SOC prostate biopsy on study. |
| Arm B (buffered lidocaine) | Experimental | Drug: Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio), Procedure: Biopsy of Prostate, Other: Questionnaire AdministrationPatients receive buffered lidocaine via injection during SOC prostate biopsy on study. (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- 18 years old or older
- Patients with prostates
- Those with and without a prior diagnosis of prostate cancer
- 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:
Key exclusion criteria (9 listed)
- Anorectal pathology precluding placement of a transrectal ultrasound
- Diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome
- Concomitant chronic pain condition
- Neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc.)
- Prostate biopsy performed with any anesthesia other than local anesthetic (monitored anesthesia care, general anesthesia)
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 |
|---|---|---|
| Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio)Given via injection | Drug | Arm B (buffered lidocaine) |
| LidocaineGiven via injection | Drug | Arm A (lidocaine) |
| Biopsy of ProstateAlso: Prostate BiopsyUndergo SOC prostate biopsy | Procedure or surgery | Arm A (lidocaine), Arm B (buffered lidocaine) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (lidocaine), Arm B (buffered lidocaine) |
Primary outcome
Pain of Local Anesthetic Injection
Time frame: Within 20 seconds of completing the injection of all local anesthetic
Pain associated with the injection of local anesthetic, assessed by a written questionnaire (Visual Analogue Scale, 0 [least] to 10 [worst pain]).
3 secondary outcomes
Pain of the Prostate Biopsy
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
Time frame: Within 10 minutes of completing the prostate biopsy, and on post-operative day 1
Incidence of adverse events
Time frame: Post-operative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No. This is a single center, investigator initiated trial.
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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. This study is not recruiting at the moment.
Alexander Zhu, DO principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Buffered Lidocaine (1% Lidocaine + 8.4% Sodium Bicarbonate, in a 3:1 ratio), Lidocaine and Biopsy of Prostate in people with Prostate Cancer, run by University of Washington at 1 site 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain of Local Anesthetic Injection (time frame: Within 20 seconds of completing the injection of all local anesthetic). 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 17 Feb 2026.