InfectionPREVENT2NCT04815876
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
A study testing Transperineal MRI-guided prostate biopsy, Transrectal MRI-guided prostate biopsy and Antibiotic (prophylaxis) in people with Infection, run by Weill Medical College of Cornell University at 16 sites in United States.
Trial summary
Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infection
- What is being tested?
- Transperineal MRI-guided prostate biopsy, Transrectal MRI-guided prostate biopsy and Antibiotic (prophylaxis)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 16 sitesUnited States
- Study dates
- 24 Jun 2021to 11 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Active surveillance cohort: History of Grade Group 1 prostate cancer, first diagnosed ≤24 months prior to date of planned confirmatory biopsy and diagnostic biopsy was preceded by a multiparametric MRI of the prostate
- Prior negative cohort: Clinical concern for the presence of prostate cancer as determined by the treating urologist and prior negative prostate biopsy performed ≤36 months prior to date of planned biopsy
- Willingness to sign informed consent and adhere to the study protocol
Who cannot join
- Acute prostatitis within the last 6 months
- Current non-urologic bacterial infection requiring active treatment with antibiotics
- Unfit to undergo prostate biopsy under local anesthesia
- Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
- Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11217
University of North Carolina
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Einstein Healthcare Network
Elkins Park, Pennsylvania, 19027
University of Connecticut
Farmington, Connecticut, 06030
NewYork-Presbyterian Queens
Flushing, New York, 11355
University of Southern California
Los Angeles, California, 90033
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy; Randomized Controlled Trial Assessing Transperineal Prostate Biopsy to Reduce Infection Complications
Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.
This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy.
The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.
Read the detailed description
Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.
However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.
Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is performed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.
Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.
Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.
Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.
This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.
- Conditions
- Infection
- Being tested
- Transperineal MRI-guided prostate biopsy, Transrectal MRI-guided prostate biopsy, Antibiotic (prophylaxis)
- Keywords
- prostate cancer, prostate biopsy, biopsy infection, fusion biopsy, MRI-targeted biopsy, transperineal, transrectal
- Medical subject headings
- Infections, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal MRI-guided prostate biopsyProcedure or surgery
Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Transrectal MRI-guided prostate biopsyProcedure or surgery
Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.
Antibiotic (prophylaxis)Drug
For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).
No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Transrectal | Active comparator | Patients will receive a transrectal MRI-guided prostate biopsy. Receives: Procedure: Transrectal MRI-guided prostate biopsy; Drug: Antibiotic (prophylaxis) |
| Transperineal | Active comparator | Patients will receive a transperineal MRI-guided prostate biopsy. Receives: Procedure: Transperineal MRI-guided prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Infection/Adverse Events, as Measured on the TRUS-Bx Questionnaire
TRUS-BxQ is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaire consists of Yes/No questions about infection complications and duration of infection.
Measured: up to 7- 10 days post-biopsy
Secondary outcomes (4)
Change in Patient-reported Pain and Discomfort, as Measured on a 0-10 Likert Scale
Pain and discomfort will be scored on a 0-10 Likert scale. 0 indicates no pain/discomfort and high scores indicate greater pain/discomfort.
Measured: Immediately following biopsy, 7 days post-biopsy
Change in Patient-reported Anxiety, as Measured on a 0-10 Likert Scale
Anxiety will be scored on a 0-10 Likert scale. 0 indicates no anxiety and high scores indicate greater anxiety.
Measured: Immediately following biopsy
Number of Participants With Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2
Gleason Grade Group is a prostate cancer grading system released by the International Society of Urological Pathology (ISUP). Grade Group 1 indicates Low/Very Low Risk, Grade Group 2 indicates Intermediate (Favorable) Risk, Grade Group 3 indicates Intermediate (Unfavorable) Risk, and Grade Groups 4 and 5 indicate High/Very High Risk.
Prostate cancer grade will be categorized into insignificant (Gleason Grade Group 1) and clinically significant (Grade Group ≥ 2).
Measured: 7 days post-biopsy
Number of Adverse Events, as Measured on TRUS-BxQ
TRUS-BxQ is a validated biopsy questionnaire that measures adverse events that have occurred, such as hospital re-admissions, aborted procedures due to discomfort, hematuria, urinary retention, hematospermia, and/or hematochezia. Patient questionnaire consists of Yes/No questions about general complications and duration of adverse events.
Measured: up to 7-10 days post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start24 Jun 2021
- Primary completion11 Oct 2025
- Study completion11 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Men enrolled in this prospective, randomized trial will be randomized in a 1:1 ratio to receive either transperineal MRI-targeted or transrectal MRI-targeted prostate biopsy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Jim C Hu, MD MPH, Principal investigator, Weill Cornell Medicine, NewYork-Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815876
- Sponsor's protocol ID
- 21-03023431
- Other IDs
- CER-2019C2-17372, 18-02-365-PCORI
- Acronym
- PREVENT2
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2021
- Last updated
- 24 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kaplan-Marans E, Zhang TR, Hu JC. Differing Recommendations on Prostate Biopsy Approach to Minimize Infections: An Examination of the European Association of Urology and American Urological Association Guidelines. Eur Urol. 2023 Nov;84(5):445-446. doi: 10.1016/j.eururo.2023.05.036. Epub 2023 Jun 7.
PubMed 37296040Hu J, Zhu A, Vickers A, Allaf ME, Ehdaie B, Schaeffer A, Pavlovich C, Ross AE, Green DA, Wang G, Ginzburg S, Montgomery JS, George A, Graham JN, Ristau BT, Correa A, Shoag JE, Kowalczyk KJ, Zhang TR, Schaeffer EM. Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications. BMJ Open. 2023 May 19;13(5):e071191. doi: 10.1136/bmjopen-2022-071191.
PubMed 37208135
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy; Randomized Controlled Trial Assessing Transperineal Prostate Biopsy to Reduce Infection Complications
- ClinicalTrials.gov ID
- NCT04815876
- Acronym / sponsor ID
- PREVENT2 / 21-03023431
- Conditions
- Infection
- Keywords
- prostate cancer, prostate biopsy, biopsy infection, fusion biopsy, MRI-targeted biopsy, transperineal, transrectal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 11 Oct 2025 (actual)
- Study completion
- 11 Oct 2025 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Posted 24 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.
This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy.
The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.
Detailed description
Prostate cancer is the most commonly diagnosed malignancy in U.S. men. There are approximately 1 million prostate biopsy performed annually in the U.S. Almost all biopsies are performed as an office based procedure in under 15 minutes. The precision of biopsy has improved over the last decade with the introduction of MRI guidance/targeting of suspicious lesions within the prostate.
However, significant limitations remain with this approach, including a significantly increasing risk of post-biopsy infection. This arises because more than 97% of all prostate biopsy are performed via a transrectal approach that introduces rectal bacteria with each pass of the biopsy needle into the sterile urinary tract. The current risk of post-transrectal biopsy infection, even with antimicrobial prophylaxis, is high at approximately 7% overall with 3% (30,000 men) requiring hospitalization annually.
Transperineal biopsy is an alternate approach that eliminates the direct introduction of bacteria from the rectum to the prostate. This approach, which is performed without antimicrobial prophylaxis, instead passes the biopsy needle through the perineal skin and pelvic floor.
Transperineal biopsy has not been widely adopted for several reasons. Historically, it has been considered too painful for patients in the clinic and thus was traditionally performed under general anesthesia. The added time, inconvenience and cost has limited its national adoptance. Second, when transrectal biopsy was initially adopted over 40 years ago, antibiotic resistance of rectal flora was not a challenge.
Beyond the potential for in-office transperineal biopsy to significantly reduce or eliminate biopsy infections, transperineal biopsy may also improve cancer detection: studies of transperineal biopsy (performed under general anesthesia) demonstrate higher detection rates for prostate cancer, particularly for anterior zone tumors, compared to transrectal biopsy. This is notable, as anterior tumors are difficult to sample with transrectal. Anterior tumors are also twice as likely to occur in African American men. In fact, our research demonstrates that some of the outcomes disparities in African American men may stem from an underdiagnosis of anterior prostate cancers.
Although transrectal biopsy is used widely, it is associated with a significant and increasing risk of biopsy infections due to growing antibiotic resistance, highlighting the urgent need for a safer alternative approach to prostate biopsy. The study investigators have refined a transperineal approach under local anesthesia with MRI-targeting/guidance without the need for antibiotic prophylaxis. The investigators hypothesize that transperineal MRI targeted biopsy will: (1) largely eliminate post-biopsy infections and costly hospitalizations for urosepsis; (2) be performed in the office with similar discomfort and non-infectious complications compared to transrectal MRI targeted biopsy; and (3) have significantly better detection of prostate cancer.
This multi-center randomized controlled trial will be conducted to evaluate in-office transperineal MRI targeted vs. transrectal MRI targeted biopsy, the current gold standard. This has transformative impact to change current standard of practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Men enrolled in this prospective, randomized trial will be randomized in a 1:1 ratio to receive either transperineal MRI-targeted or transrectal MRI-targeted prostate biopsy.
| Arm | Type | Receives |
|---|---|---|
| Transrectal | Active comparator | Procedure: Transrectal MRI-guided prostate biopsy, Drug: Antibiotic (prophylaxis)Patients will receive a transrectal MRI-guided prostate biopsy. |
| Transperineal | Active comparator | Procedure: Transperineal MRI-guided prostate biopsyPatients will receive a transperineal MRI-guided prostate biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active surveillance cohort: History of Grade Group 1 prostate cancer, first diagnosed ≤24 months prior to date of planned confirmatory biopsy and diagnostic biopsy was preceded by a multiparametric MRI of the prostate
- Prior negative cohort: Clinical concern for the presence of prostate cancer as determined by the treating urologist and prior negative prostate biopsy performed ≤36 months prior to date of planned biopsy
- Willingness to sign informed consent and adhere to the study protocol
Key exclusion criteria (5 listed)
- Acute prostatitis within the last 6 months
- Current non-urologic bacterial infection requiring active treatment with antibiotics
- Unfit to undergo prostate biopsy under local anesthesia
- Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
- Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)
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 |
|---|---|---|
| Transperineal MRI-guided prostate biopsyTransperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking. | Procedure or surgery | Transperineal |
| Transrectal MRI-guided prostate biopsyTransrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. | Procedure or surgery | Transrectal |
| Antibiotic (prophylaxis)For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy. | Drug | Transrectal |
Primary outcome
Number of Participants With Infection/Adverse Events, as Measured on the TRUS-Bx Questionnaire
Time frame: up to 7- 10 days post-biopsy
TRUS-BxQ is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaire consists of Yes/No questions about infection complications and duration of infection.
4 secondary outcomes
Change in Patient-reported Pain and Discomfort, as Measured on a 0-10 Likert Scale
Time frame: Immediately following biopsy, 7 days post-biopsy
Change in Patient-reported Anxiety, as Measured on a 0-10 Likert Scale
Time frame: Immediately following biopsy
Number of Participants With Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2
Time frame: 7 days post-biopsy
Number of Adverse Events, as Measured on TRUS-BxQ
Time frame: up to 7-10 days post-biopsy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37296040Kaplan-Marans E, Zhang TR, Hu JC. Differing Recommendations on Prostate Biopsy Approach to Minimize Infections: An Examination of the European Association of Urology and American Urological Association Guidelines. Eur Urol. 2023 Nov;84(5):445-446. doi: 10.1016/j.eururo.2023.05.036. Epub 2023 Jun 7.
- Derived from this study: PubMed 37208135Hu J, Zhu A, Vickers A, Allaf ME, Ehdaie B, Schaeffer A, Pavlovich C, Ross AE, Green DA, Wang G, Ginzburg S, Montgomery JS, George A, Graham JN, Ristau BT, Correa A, Shoag JE, Kowalczyk KJ, Zhang TR, Schaeffer EM. Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications. BMJ Open. 2023 May 19;13(5):e071191. doi: 10.1136/bmjopen-2022-071191.
- Individual participant dataSharing planned: No
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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.
Jim C Hu, MD MPH principal investigator
Weill Cornell Medicine, NewYork-Presbyterian
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal MRI-guided prostate biopsy, Transrectal MRI-guided prostate biopsy and Antibiotic (prophylaxis) in people with Infection, run by Weill Medical College of Cornell University at 16 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 3 inclusion and 5 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Infection/Adverse Events, as Measured on the TRUS-Bx Questionnaire (time frame: up to 7- 10 days post-biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04815876, which also lists 2 linked publications.
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 24 Aug 2026.