Prostate Biopsy Techniques for Reducing Infection Risk

(PREVENT2 Trial)

Recruiting at 16 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for prostate biopsies to determine which one carries a lower risk of infection. One method uses a transperineal approach (through the skin between the anus and scrotum), while the other uses a transrectal approach (through the rectum). The researchers aim to determine if the transperineal method is safer and equally effective at detecting prostate cancer. Suitable candidates for this trial include men with low-risk prostate cancer or those who have had a negative prostate biopsy but still exhibit signs of concern for cancer. Participants must be able to undergo a prostate biopsy with local anesthesia. As an unphased trial, this study allows participants to contribute to important research that could enhance the safety and effectiveness of prostate biopsies.

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 prior data suggests that these prostate biopsy techniques are safe?

Research has shown that a transperineal MRI-guided prostate biopsy carries a lower risk of infection than the transrectal method. Studies indicate that the transperineal approach reduces the likelihood of rectal bleeding, fever, urinary tract infections, and severe infections like sepsis. This method is often so safe that antibiotics might not be necessary.

In contrast, while the transrectal MRI-guided prostate biopsy is generally well-tolerated, it presents a higher risk of infection compared to the transperineal technique. Infections remain the main concern, with some cases leading to severe infections like sepsis.

Overall, evidence suggests that the transperineal biopsy may be a safer choice regarding infection risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different biopsy techniques that might reduce infection risks in prostate cancer diagnosis. The transperineal MRI-guided biopsy is unique because it accesses the prostate through the skin between the anus and scrotum, potentially lowering infection rates compared to the more common transrectal method, which involves passing through the rectum. By comparing these techniques, researchers hope to determine which method provides the safest, most effective approach for patients, potentially leading to a new standard of care that minimizes complications.

What evidence suggests that the transperineal MRI-targeted biopsy approach is effective for reducing infection risk?

This trial will compare two biopsy methods: the transperineal MRI-guided prostate biopsy and the transrectal MRI-guided prostate biopsy. Research has shown that the transperineal method results in fewer infections than the transrectal method. In one study, the transperineal group reported no infections, while the transrectal group experienced several. The transperineal method also reduces the risk of complications such as rectal bleeding and fever and may be more effective in detecting significant prostate cancer. These findings suggest that the transperineal method could offer a safer and more effective option for prostate biopsies. ^{4 5 6 7 8}

Who Is on the Research Team?

Jim C Hu, MD MPH

Principal Investigator

Weill Cornell Medicine, NewYork-Presbyterian

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12076238/

insights into transperineal vs. transrectal prostate biopsy The TP arm still reported no infections, while the TR group had six grade 2 infections (7). Additional studies have suggested similar type ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04081636

Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and ... This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2287888225000856

Transperineal vs. Transrectal MRI-Fusion Ultrasound ... Moreover, MRI–ultrasound fusion-guided prostate biopsy has demonstrated superior performance in the detection of clinically significant prostate ...

4. nature.com nature.com/articles/s41391-024-00934-9

Infectious complications following transperineal prostate ... Despite the relatively low infection rate following transperineal prostate biopsy (TPB), it remains unresolved whether periprocedural ...

5. urologyresearchandpractice.org urologyresearchandpractice.org/Content/files/sayilar/219/URP_20240094_nlm_new_indd(1).pdf

Meta Analysis of Efficacy and Safety of Prostate Biopsy TP prostate biopsy significantly reduces the risk of rectal bleed- ing, fever/urinary tract infections, and sepsis compared to the. TR method. • ...

6. mayoclinic.org mayoclinic.org/medical-professionals/urology/news/ultrasound-guided-transperineal-prostate-biopsy/mac-20473283

Ultrasound-guided transperineal prostate biopsy "The main benefit is safety, due to the lower risk of severe life-threatening infection. Also, with a transperineal approach it is much easier ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11883667/

Meta Analysis of Efficacy and Safety of Prostate Biopsy TP prostate biopsy significantly reduces the risk of rectal bleeding, fever/urinary tract infections, and sepsis compared to the TR method.

8. my.clevelandclinic.org my.clevelandclinic.org/health/diagnostics/16382-mri-guided-prostate-biopsy

MRI-Guided Prostate Biopsy: How It Works Often, antibiotics aren't often necessary for a transperineal prostate biopsy due to the low risk of infection. ... What happens during a transperineal MRI-guided ...