840 Participants Needed

Transrectal vs. Transperineal Biopsy for Prostate Cancer

(ProBE-PC Trial)

BR
BM
Overseen ByBadar M Mian
Age: Any Age
Sex: Male
Trial Phase: Academic
Sponsor: Albany Medical College
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.14678

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.12459

Research Team

Dr. Badar M. Mian, MD | Albany, NY ...

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
4Treatment groups
Experimental Treatment
Active Control
Group I: Targeted Transperineal biopsy (TP-Bx)Experimental Treatment1 Intervention
MRI-guided; needle inserted directly through the skin to reach the prostate
Group II: Systematic Transperineal biopsy (TP-Bx)Experimental Treatment1 Intervention
Ultrasound guided; needle inserted directly through the skin to reach the prostate
Group III: Systematic Transrectal biopsy (TR-Bx)Active Control1 Intervention
Ultrasound guided; needle inserted through the rectum to reach the prostate
Group IV: Targeted Transrectal biopsy (TR-Bx)Active Control1 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:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Systematic Transperineal Biopsy for:
  • Diagnosis of prostate cancer
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Approved in United States as Systematic Transperineal Biopsy for:
  • Diagnosis of prostate cancer
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Approved in Canada as Systematic Transperineal Biopsy for:
  • Diagnosis of prostate cancer

Find a Clinic Near You

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.
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.
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.
Complication Rate After Antibiotic Prophylaxis with Fosfomycin Versus Fluorochinolones or Ξ²-lactam Antibiotics in Patients Undergoing Prostate Biopsy: A Propensity Score-adjusted Analysis.Cimino, S., Verze, P., Venturino, L., et al.[2021]

References

Initial transperineal prostate biopsy experience at a high-volume center. [2021]
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]
Complication Rate After Antibiotic Prophylaxis with Fosfomycin Versus Fluorochinolones or Ξ²-lactam Antibiotics in Patients Undergoing Prostate Biopsy: A Propensity Score-adjusted Analysis. [2021]
Transperineal versus transrectal multi-parametric magnetic resonance imaging fusion targeted prostate biopsy. [2023]
Free-hand transperineal prostate biopsy provides acceptable cancer detection and minimizes risk of infection: evolving experience with a 10-sector template. [2019]
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]
Should Transperineal Prostate Biopsy Be the Standard of Care? [2023]
Prospective evaluation of the safety of transrectal ultrasound-guided transperineal prostate biopsy based on adverse events. [2019]
A retrospective comparison between transrectal and transperineal prostate biopsy in the detection of prostate cancer. [2022]
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