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

Trial Summary

What is the purpose of this trial?

This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy. Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal approach. This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.

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 data supports the effectiveness of this treatment for prostate cancer?

Research shows that transperineal prostate biopsy (TPBx) is effective in detecting prostate cancer with fewer infections compared to the transrectal approach. Studies indicate that TPBx has comparable cancer detection rates to traditional methods while minimizing the risk of infection. ^{1 2 3 4 5}

Is prostate biopsy safe for humans?

Transrectal prostate biopsy (TRUS-Bx) is generally considered safe, but there has been an increase in infectious complications. Transperineal prostate biopsy (TPBx) is associated with fewer infectious complications compared to transrectal biopsy. ^{1 4 6 7 8}

How does the transperineal biopsy treatment for prostate cancer differ from other treatments?

Transperineal biopsy (TP-Bx) for prostate cancer is unique because it reduces the risk of infection compared to the traditional transrectal biopsy (TR-Bx), as it avoids passing through the rectum. This method also allows for targeted sampling of the prostate, potentially improving cancer detection rates. ^{1 2 4 5 9}

Research Team

Badar M. Mian, MD

Principal Investigator

Albany Medical College

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 (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 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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Initial transperineal prostate biopsy experience at a high-volume center. [2021]

2. Netherlands 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. [2023]

3. Netherlands 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. [2021]

4. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Transperineal versus transrectal multi-parametric magnetic resonance imaging fusion targeted prostate biopsy. [2023]

5. United States 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. [2019]

6. Netherlands 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. [2020]

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

Should Transperineal Prostate Biopsy Be the Standard of Care? [2023]

8. Japan pubmed.ncbi.nlm.nih.gov

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

9. Italy pubmed.ncbi.nlm.nih.gov

A retrospective comparison between transrectal and transperineal prostate biopsy in the detection of prostate cancer. [2022]