Transrectal vs. Transperineal Biopsy for Prostate Cancer (ProBE-PC Trial)
Palo Alto (17 mi)Age: Any Age
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Albany Medical College
No Placebo Group
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 have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. It's best to ask the trial coordinators for more information.
Is the treatment of prostate cancer using transperineal or transrectal biopsy promising?Yes, the transperineal biopsy (TP-Bx) is promising because it detects prostate cancer effectively and has fewer risks of infection compared to the transrectal biopsy (TR-Bx).25679
What safety data is available for transrectal and transperineal prostate biopsies?Transrectal prostate biopsy (TRUS-Bx) is generally considered safe, but there is an increasing trend in infectious complications. Transperineal prostate biopsy (TP-Bx) is gaining popularity due to fewer infectious complications compared to TRUS-Bx. However, comprehensive safety evaluations for TP-Bx are limited, though initial experiences suggest it may be safer.13678
What data supports the idea that Transrectal vs. Transperineal Biopsy for Prostate Cancer is an effective treatment?The available research shows that transperineal prostate biopsy (TPBx) is effective for detecting prostate cancer and has fewer infection risks compared to transrectal prostate biopsy (TRUSBx). Studies indicate that TPBx provides similar cancer detection rates to TRUSBx but with a lower chance of complications like urinary tract infections. This suggests that TPBx is a safer option while still being effective in diagnosing prostate cancer.45679
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.
Treatment Details
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.
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, Australia for the following indications:
πͺπΊ Approved in European Union as Systematic Transperineal Biopsy for:
- Diagnosis of prostate cancer
πΊπΈ Approved in United States as Systematic Transperineal Biopsy for:
- Diagnosis of prostate cancer
π¨π¦ Approved in Canada as Systematic Transperineal Biopsy for:
- Diagnosis of prostate cancer
π¦πΊ Approved in Australia as Systematic Transperineal Biopsy for:
- Diagnosis of prostate cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Albany Medical CollegeAlbany, NY
Loading ...
Who is running the clinical trial?
Albany Medical CollegeLead Sponsor
References
Prospective evaluation of the safety of transrectal ultrasound-guided transperineal prostate biopsy based on adverse events. [2019]Although transperineal (TP) prostate biopsy is growing in popularity, its safety has not been evaluated based on extensive studies. We prospectively assessed the adverse events associated with transrectal ultrasound (TRUS)-guided TP 16-core prostate biopsy at a single institution.
A retrospective comparison between transrectal and transperineal prostate biopsy in the detection of prostate cancer. [2022]The aim of this study was to analyze the differences between TRUSguided transrectal prostate biopsy (TR) and transperineal prostate biopsy (TP) in the diagnosis of prostate cancer. The two biopsy methods were evaluated in terms of diagnostic sensitivity and of early and late complications.
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]Transrectal ultrasound-guided prostate biopsy (TRUS-Bx) is typically considered a safe procedure. However, infectious complications have been increasing.
Complication Rate After Antibiotic Prophylaxis with Fosfomycin Versus Fluorochinolones or Ξ²-lactam Antibiotics in Patients Undergoing Prostate Biopsy: A Propensity Score-adjusted Analysis. [2021]Transrectal ultrasound-guided prostate biopsy (TRBx) or transperineal Bx (TPBx) are considered alternative approaches for the diagnosis of prostate cancer (PCa). However, urinary tract infection (UTI) or other complications could be more frequent in the TRBx approach.
Free-hand transperineal prostate biopsy provides acceptable cancer detection and minimizes risk of infection: evolving experience with a 10-sector template. [2019]Free-hand transperineal prostate (fTP-Bx) biopsy offers an alternative to transrectal prostate biopsy (TRUS-Bx) in the diagnosis of prostate cancer. Our objectives were to determine whether fTP-Bx achieves cancer detection rates comparable to historic TRUS-Bx cohorts; to determine infectious and other complications associated with fTP-B; and to propose a standardized fTP-Bx template.
Transperineal versus transrectal multi-parametric magnetic resonance imaging fusion targeted prostate biopsy. [2023]To compare transperineal biopsies (TPBx) with transrectal ultrasound-guided biopsy (TRUSBx) in order to provide evidence, making clinicians able to select the appropriate biopsy approach under different conditions.
Initial transperineal prostate biopsy experience at a high-volume center. [2021]Transperineal prostate biopsy (TPBx) allows for prostate cancer detection with fewer infectious complications when compared to transrectal prostate biopsy (TRUSBx). We evaluated the initial experience of a single physician with no prior TPBx exposure, compared to TRUSBx and MRI/US fusion biopsy (MRIBx) performed by experienced physicians.
Should Transperineal Prostate Biopsy Be the Standard of Care? [2023]We reviewed the advantages and disadvantages of transperineal prostate biopsy (TP-bx) to evaluate its potential role as the standard of care for prostate biopsy.
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]The concordance rates of transperineal (TP) versus transrectal (TR) prostate biopsies with radical prostatectomy (RP) specimen have been assessed poorly in men diagnosed with magnetic resonance imaging (MRI)-targeted biopsy (TBx).