Transrectal vs. Transperineal Biopsy for Prostate Cancer

(ProBE-PC Trial)

Overseen By Badar M Mian

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: Albany Medical College

Disqualifiers: No rectum access, Perineal abnormalities, Sedation required

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

840 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for prostate biopsies: transrectal (through the rectal wall) and transperineal (through the skin). The goal is to determine which method more effectively detects prostate cancer while causing fewer complications. Men needing a prostate biopsy due to suspected cancer may be suitable candidates. Participants will be randomly assigned to one of the two methods to compare outcomes. As an unphased trial, this study provides participants the chance to contribute to important research that could enhance prostate cancer detection methods.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these biopsy methods are safe for prostate cancer diagnosis?

Research has shown that the transperineal (TP) biopsy method is generally safer than the transrectal (TR) approach. Studies have found that TP biopsy significantly reduces the risk of rectal bleeding, fever, urinary tract infections, and sepsis compared to the TR method. Both methods are equally accurate in detecting prostate cancer, so safety often guides the choice.

The TR biopsy carries a higher risk of infections. In contrast, the TP biopsy usually results in fewer complications, making it a well-tolerated option for many patients. Overall, both methods aim to provide accurate results, but the TP biopsy may offer a safer experience with fewer side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial comparing transrectal and transperineal biopsy techniques for prostate cancer because each method offers distinct advantages in terms of accuracy and patient comfort. Unlike the traditional transrectal biopsies, which involve inserting a needle through the rectum and can carry a higher risk of infection, transperineal biopsies involve guiding the needle directly through the skin, potentially reducing infection risk. The trial also explores the use of MRI guidance for targeted biopsies, which could improve the precision in detecting cancerous areas compared to the systematic ultrasound-guided approach. By comparing these techniques, researchers hope to determine which method offers the best combination of safety, accuracy, and patient experience.

What evidence suggests that this trial's biopsy methods could be effective for prostate cancer?

This trial will compare the effectiveness and safety of different biopsy methods for prostate cancer. Research has shown that both the transrectal (through the rectum) and transperineal (through the skin) methods are similarly effective at detecting prostate cancer. One study found that the transrectal method detected significant prostate cancer in 47.1% of cases, while the transperineal method found it in 43.2% of cases. Although both methods are similarly accurate, the transperineal approach significantly reduces the risk of complications such as rectal bleeding, infections, and sepsis (a serious systemic infection). The overall cancer detection rates are also comparable, with transrectal at 72.1% and transperineal at 70.4%. This suggests both methods are reliable, but the transperineal biopsy may have fewer side effects. Participants in this trial will be assigned to one of the various treatment arms to further evaluate these findings. ^{1 2 6 7 8}

Who Is on the Research Team?

Badar M. Mian, MD

Principal Investigator

Albany Medical College

Are You a Good Fit for This Trial?

Men needing a prostate biopsy due to suspected cancer, who can undergo the procedure without sedation or general anesthesia. They must have access to their rectum (no prior surgery blocking it) and no perineal skin abnormalities like infections.

Inclusion Criteria

I am scheduled for a prostate biopsy to check for cancer.

Exclusion Criteria

I cannot access my rectum due to past surgery.

My upcoming procedure needs me to be sedated or under general anesthesia.

I have no skin infections or abnormalities in the perineal area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either transrectal or transperineal prostate biopsy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for complications and cancer detection outcomes

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Systematic Transperineal biopsy (TP-Bx)
• Systematic Transrectal biopsy (TR-Bx)
• Targeted Transperineal biopsy (TP-Bx)
• Targeted Transrectal biopsy (TR-Bx)

Trial Overview The study is comparing two methods of prostate biopsy: transrectal (needle through the rectal wall) and transperineal (needle through the skin). Participants will be randomly assigned to one of these methods to see which is more effective and has fewer complications.

How Is the Trial Designed?

Group I: Targeted Transperineal biopsy (TP-Bx) Experimental Treatment 1 Intervention

MRI-guided; needle inserted directly through the skin to reach the prostate

Group II: Systematic Transperineal biopsy (TP-Bx) Experimental Treatment 1 Intervention

Ultrasound guided; needle inserted directly through the skin to reach the prostate

Group III: Systematic Transrectal biopsy (TR-Bx) Active Control 1 Intervention

Ultrasound guided; needle inserted through the rectum to reach the prostate

Group IV: Targeted Transrectal biopsy (TR-Bx) Active Control 1 Intervention

MRI-guided; needle inserted through the rectum to reach the prostate

Systematic Transperineal biopsy (TP-Bx) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Systematic Transperineal Biopsy for:

• Diagnosis of prostate cancer

Approved in United States as Systematic Transperineal Biopsy for:

• Diagnosis of prostate cancer

Approved in Canada as Systematic Transperineal Biopsy for:

• Diagnosis of prostate cancer

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials

96

Recruited

12,700+

Published Research Related to This Trial

Transperineal prostate biopsy (TP-bx) shows similar cancer detection rates compared to traditional transrectal biopsy (TR-bx), but may be better at detecting tumors located in the anterior part of the prostate.

TP-bx has become a more tolerable office-based procedure due to advancements in anesthetic techniques and a low rate of infectious complications, suggesting it should be considered the standard of care for prostate biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should Transperineal Prostate Biopsy Be the Standard of Care? Wilcox Vanden Berg, RN., George, AK., Kaye, DR.[2023]

In a study of 526 patients undergoing prostate biopsies, those receiving fosfomycin trometamol (FT) had a lower rate of urinary tract infections (34.1%) compared to those receiving fluoroquinolones or ß-lactam antibiotics (43.4%).

The study suggests that using FT for antimicrobial prophylaxis may reduce UTI risk in patients undergoing transrectal or transperineal prostate biopsies, highlighting the importance of selecting appropriate antibiotics to minimize complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complication Rate After Antibiotic Prophylaxis with Fosfomycin Versus Fluorochinolones or β-lactam Antibiotics in Patients Undergoing Prostate Biopsy: A Propensity Score-adjusted Analysis. Cimino, S., Verze, P., Venturino, L., et al.[2021]

Transperineal targeted biopsy (TP-TBx) shows improved concordance with final pathology compared to transrectal targeted biopsy (TR-TBx), indicating better accuracy in diagnosing prostate cancer, based on a study involving 1,282 patients.

TP-TBx is associated with a lower risk of upgrading cancer grades and clinically relevant increases in disease severity, suggesting it may lead to better patient outcomes and more appropriate treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There an Impact of Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted Biopsy on the Risk of Upgrading in Final Pathology in Prostate Cancer Patients Undergoing Radical Prostatectomy? An European Association of Urology-Young Academic Urologists Prostate Cancer Working Group Multi-institutional Study. Zattoni, F., Marra, G., Martini, A., et al.[2023]

Transperineal biopsies (TPBx) showed a significantly higher cancer detection rate (45.1%) and clinically significant cancer detection rate (71.8%) compared to transrectal ultrasound-guided biopsies (TRUSBx) with rates of 29.1% and 43.7%, respectively, based on a study conducted with patients undergoing MRI-guided biopsies.

Both biopsy methods had similar complication rates, but TPBx took longer to perform (41.2 minutes) compared to TRUSBx (13 minutes), indicating that while TPBx is more effective for detecting cancer, it requires more time to complete.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transperineal versus transrectal multi-parametric magnetic resonance imaging fusion targeted prostate biopsy. Rabah, D., Al-Taweel, W., Khan, F., et al.[2023]

Free-hand transperineal prostate biopsy (fTP-Bx) achieved cancer detection rates comparable to traditional transrectal biopsy (TRUS-Bx), with a total cancer detection rate of 60.7% and clinically significant cancer detection rate of 40.3% in a study of 1,000 men.

The use of a 10-sector biopsy template in fTP-Bx significantly improved cancer detection rates compared to a fan-like pattern, while also demonstrating a nearly zero risk of infection, as no patients experienced hospitalization for sepsis or urinary tract infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free-hand transperineal prostate biopsy provides acceptable cancer detection and minimizes risk of infection: evolving experience with a 10-sector template. Ristau, BT., Allaway, M., Cendo, D., et al.[2019]

Transperineal (TP) prostate biopsy detected a higher percentage of cancers during the first biopsy compared to transrectal (TR) biopsy (89.7% vs 78.4%), indicating it may be more effective for initial cancer detection.

While both biopsy methods showed similar overall cancer detection rates, TP biopsy had a lower late complication rate (4% vs 11% for TR biopsy), suggesting it may be a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective comparison between transrectal and transperineal prostate biopsy in the detection of prostate cancer. Di Franco, CA., Jallous, H., Porru, D., 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]

In a study of 294 patients undergoing transrectal ultrasound-guided prostate biopsy (TRUS-Bx), the overall rate of biopsy-related complications was low at 4.1%, with only 0.7% being infectious complications that were manageable in an outpatient setting.

Despite the low complication rates, 11% of patients had E. coli strains resistant to the prophylactic antibiotics used, indicating a significant concern for antibiotic resistance that could impact the effectiveness of standard prophylactic measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Complications Leading to a Health Care Contact After Transrectal Prostate Biopsies: A Prospective, Controlled, Multicenter Study Based on a Selected Study Cohort. Knaapila, J., Gunell, M., Syvänen, K., et al.[2020]

Transperineal prostate biopsy (TPBx) demonstrated significantly fewer infectious complications compared to transrectal prostate biopsy (TRUSBx), with no complications reported in the TPBx group of 92 patients, while the TRUSBx group had nine complications including two cases of sepsis.

Despite being performed by a physician with no prior TPBx experience, the procedure was well tolerated, showing similar discomfort levels to TRUSBx and MRI/US fusion biopsy (MRIBx), and achieved comparable cancer detection rates, indicating that TPBx is a safe and effective alternative for prostate cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial transperineal prostate biopsy experience at a high-volume center. Berkenwald, A., Stensland, KD., Sebel, LE., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39095298/

A Systematic Review and Meta-analysis of Prospective ... TP-Tbx and TR-Tbx show similar results in detecting PCa, with comparable rates of infections, urinary retention, and effectiveness in managing biopsy- ...

2. 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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04081636

NCT04081636 | Prostate Biopsy, Transrectal vs. ... This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.

4. cureus.com cureus.com/articles/323791-comparing-the-efficacy-and-safety-of-the-transperineal-versus-transrectal-prostate-biopsy-approach-in-the-diagnosis-of-prostate-cancer-a-systematic-review-and-meta-analysis

Comparing the Efficacy and Safety of the Transperineal ... The transperineal (TP) and transrectal (TR) prostate biopsy approaches demonstrate comparable diagnostic accuracy for prostate cancer detection.

5. urotoday.com urotoday.com/conference-highlights/eau-2024/eau-2024-prostate-cancer/151071-eau-2024-efficacy-of-transrectal-and-transperineal-prostate-biopsy-in-detecting-clinically-significant-prostate-cancer-results-of-the-probe-pc-randomised-clinical-trial.html

Results of the ProBE-PC Randomised Clinical Trial With regards to Grade Group ≥2 prostate cancer detection rates, transrectal biopsies detected such lesions in 47.1% of cases, compared to 43.2% ...

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

Meta Analysis of Efficacy and Safety of Prostate Biopsy The study compares transperineal (TP) and transrectal (TR) prostate biopsies, finding no significant difference in cancer detection rates but ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456925002408

Review of Transperineal and Transrectal Prostate Biopsy ... Trials have shown that TR biopsy has a higher risk of infectious complications and a similar cancer detection rate. Guidelines are therefore ...

8. mdpi.com mdpi.com/2075-4418/14/17/1864

Targeted Prostate Biopsy: How, When, and Why? A ... In a systematic review, both transperineal biopsy and transrectal prostate biopsy methods demonstrated comparable diagnostic accuracy for ...