Prostate Biopsy Techniques for Reducing Infection Risk

(PREVENT2 Trial)

Recruiting at 15 trial locations

Overseen By Xiaohong Jing, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must not be taking: Antibiotics

Disqualifiers: Acute prostatitis, Non-urologic infection, others

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

Compensation: Varies

Number of Visits: 3

1302 Participants Needed

Trial Summary

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.

What data supports the effectiveness of this treatment for reducing infection risk in prostate biopsies?

Research suggests that using MRI-targeted biopsies, whether transrectally or transperineally, can improve prostate cancer diagnosis. These techniques may also reduce complications compared to traditional methods, potentially lowering infection risks. ^{1 2 3 4 5}

Is prostate biopsy generally safe for humans?

Research shows that different prostate biopsy techniques, such as transrectal ultrasound (TRUS) and transperineal methods, have been evaluated for safety. While complications can occur, studies are ongoing to improve safety and reduce risks associated with these procedures. ^{1 3 4 6 7}

How is the Transperineal MRI-guided prostate biopsy treatment different from other prostate biopsy techniques?

The Transperineal MRI-guided prostate biopsy is unique because it combines MRI imaging with a transperineal approach, which may reduce infection risk compared to the traditional transrectal method. This technique uses advanced imaging to better target suspicious areas, potentially improving the detection of significant prostate cancer. ^{1 3 4 7 8}

What is the purpose of this trial?

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.

Research Team

Jim C Hu, MD MPH

Principal Investigator

Weill Cornell Medicine, NewYork-Presbyterian

Eligibility Criteria

Men with concerns of prostate cancer, having had a negative biopsy within the last 3 years or history of low-grade prostate cancer diagnosed in the past 2 years are eligible. They must be able to undergo local anesthesia and MRI unless they have acute prostatitis, prior cancer treatments like radiation, contraindications to MRI, or active infections treated with antibiotics.

Inclusion Criteria

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

I was diagnosed with low-grade prostate cancer within the last 2 years and had an MRI before my biopsy.

Willingness to sign informed consent and adhere to the study protocol

Exclusion Criteria

I cannot have a prostate MRI due to claustrophobia, having a pacemaker, or kidney issues.

I cannot have a prostate biopsy with local anesthesia.

I have had treatment aimed at curing my prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy Procedure

Participants undergo either a transperineal or transrectal MRI-guided prostate biopsy

1 day

1 visit (in-person)

Immediate Post-Biopsy Monitoring

Participants are monitored for immediate adverse events and discomfort following the biopsy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the biopsy, including infection and adverse events

1 week

1 visit (virtual or in-person)

Treatment Details

Interventions

• Antibiotic (prophylaxis)
• Transperineal MRI-guided prostate biopsy
• Transrectal MRI-guided prostate biopsy

Trial Overview This study compares two types of prostate biopsies: transperineal (through the skin) and transrectal (through the rectum), both guided by MRI. The goal is to see if the transperineal approach reduces infection risk while still being comfortable and effective at detecting cancer.

Participant Groups

Group I: Transrectal Active Control 2 Interventions

Patients will receive a transrectal MRI-guided prostate biopsy.

Group II: Transperineal Active Control 1 Intervention

Patients will receive a transperineal MRI-guided prostate biopsy.

Transperineal MRI-guided prostate biopsy is already approved in European Union, United States for the following indications:

Approved in European Union as Transperineal MRI-Guided Prostate Biopsy for:

• Prostate cancer diagnosis

Approved in United States as Transperineal MRI-Guided Prostate Biopsy for:

• Prostate cancer diagnosis

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

MRI-guided prostate biopsies, with or without transrectal ultrasound (TRUS) fusion, can reduce unnecessary biopsies and improve the detection of high-risk prostate cancers that may be missed by standard TRUS biopsies.

While template mapping biopsy is the most accurate for assessing tumor volume and grade, it has a higher incidence of side effects compared to TRUS biopsy, indicating a trade-off between accuracy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond transrectal ultrasound-guided prostate biopsies: available techniques and approaches. Warlick, C., Futterer, J., Maruf, M., et al.[2020]

In a randomized controlled trial involving 175 biopsy-naïve patients, the detection rates of clinically significant prostate cancer (csPCa) were similar between MRI/TRUS-guided targeted biopsy and traditional 12-core random biopsy, indicating that both methods are effective for cancer detection.

The study found that two-core targeted biopsy using MRI/TRUS detected 87% of csPCa cases identified in the MRI group, suggesting that this targeted approach could potentially replace the more invasive 12-core random biopsy without compromising detection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial To Assess and Compare the Outcomes of Two-core Prostate Biopsy Guided by Fused Magnetic Resonance and Transrectal Ultrasound Images and Traditional 12-core Systematic Biopsy. Baco, E., Rud, E., Eri, LM., et al.[2022]

MRI-guided transperineal biopsy (MRI-TPB) significantly improves detection rates for clinically significant prostate cancer (csPCa) compared to MRI-guided transrectal ultrasound fusion biopsy (MRI-TRUSB), with a relative risk of 1.28 based on a pooled analysis of five studies.

MRI-TPB also has lower complication rates than MRI-TRUSB, suggesting it may be a safer option for patients, despite the overall evidence quality being rated as 'very low'.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging/Ultrasound Fusion-guided Transperineal Versus Magnetic Resonance Imaging/Ultrasound Fusion-guided Transrectal Prostate Biopsy-A Systematic Review. Rai, BP., Mayerhofer, C., Somani, BK., et al.[2022]

In a study of 967 men comparing transrectal ultrasound (TRUS) systematic prostate biopsy and MRI-TRUS fusion prostate biopsy, both techniques showed low complication rates, with no severe complications reported.

There was no significant difference in complication rates between the two biopsy methods, indicating that both are safe options for prostate biopsy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of complications rates between multiparametric magnetic resonance imaging-transrectal ultrasound (TRUS) fusion and systematic TRUS prostatic biopsies. Queiroz, MRG., Falsarella, PM., Mariotti, GC., et al.[2020]

Using multiparametric MRI (mpMRI) followed by MRI-targeted biopsy in men with suspected prostate cancer is more effective than traditional transrectal ultrasound (TRUS)-guided biopsy, resulting in fewer total biopsies (600 vs 1000) and better identification of clinically significant cancer cases (320 vs 250).

The mpMRI approach also reduces the number of false positives (20 vs 50), demonstrating its superiority in accurately diagnosing prostate cancer, as confirmed by probabilistic sensitivity analysis showing it dominated TRUS-guided biopsy in 86% of simulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric MRI followed by targeted prostate biopsy for men with suspected prostate cancer: a clinical decision analysis. Willis, SR., Ahmed, HU., Moore, CM., et al.[2022]

In a study of 2,086 men undergoing transrectal ultrasound-guided transperineal prostate biopsy, the procedure was found to be safe, with only minor adverse events reported, including hematuria in 73.4% of cases, which lasted an average of 4.5 days.

The cancer detection rate was 53.5%, indicating that this biopsy method is effective in diagnosing prostate cancer while maintaining a low incidence of serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of the safety of transrectal ultrasound-guided transperineal prostate biopsy based on adverse events. Namekawa, T., Fukasawa, S., Komaru, A., et al.[2019]

The shift from traditional transrectal ultrasound guided biopsies to MRI-guided targeted biopsies is driven by the limitations of the former and advancements in MRI technology, which enhance the detection of clinically significant prostate tumors.

The PROMIS trial has provided evidence supporting the effectiveness of MRI in identifying significant cancers, prompting ongoing research to further improve the safety and cancer detection rates of prostate biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current techniques of prostate biopsy: an update from past to present. Noureldin, ME., Connor, MJ., Boxall, N., et al.[2021]

Fusion-guided prostate biopsy, which combines MRI with real-time transrectal ultrasound (TRUS), has been shown to significantly improve the detection of clinically significant prostate cancer in selected patients.

This method enhances the standard 12-14 core systematic biopsy approach, making it a more effective option for diagnosing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Ultrasound Fusion-Guided Prostate Biopsy: Review of Technology, Techniques, and Outcomes. Kongnyuy, M., George, AK., Rastinehad, AR., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Beyond transrectal ultrasound-guided prostate biopsies: available techniques and approaches. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial To Assess and Compare the Outcomes of Two-core Prostate Biopsy Guided by Fused Magnetic Resonance and Transrectal Ultrasound Images and Traditional 12-core Systematic Biopsy. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging/Ultrasound Fusion-guided Transperineal Versus Magnetic Resonance Imaging/Ultrasound Fusion-guided Transrectal Prostate Biopsy-A Systematic Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of complications rates between multiparametric magnetic resonance imaging-transrectal ultrasound (TRUS) fusion and systematic TRUS prostatic biopsies. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Multiparametric MRI followed by targeted prostate biopsy for men with suspected prostate cancer: a clinical decision analysis. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Prospective evaluation of the safety of transrectal ultrasound-guided transperineal prostate biopsy based on adverse events. [2019]

7. China pubmed.ncbi.nlm.nih.gov

Current techniques of prostate biopsy: an update from past to present. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Ultrasound Fusion-Guided Prostate Biopsy: Review of Technology, Techniques, and Outcomes. [2022]