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ProBE-PC: Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications

Sponsor
Albany Medical College (Other)
Overall Status
Recruiting
CT.gov ID
NCT04081636
Collaborator
(none)
568
Enrollment
1
Location
4
Arms
38.7
Anticipated Duration (Months)
14.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Systematic Transrectal biopsy (TR-Bx)
  • Procedure: Targeted Transrectal biopsy (TR-Bx)
  • Procedure: Systematic Transperineal biopsy (TP-Bx)
  • Procedure: Targeted Transperineal biopsy (TP-Bx)
 N/A

Detailed Description

There are two ways to take biopsy (tissue) samples from the prostate. The more commonly used method is trans-rectal needle biopsy of the prostate (TR-Bx) with a needle inserted through a probe in the rectum to reach the prostate.

TR-Bx is usually performed in the office, using local anesthesia, and often using a targeted biopsy approach using MRI/ultrasound fusion technique.

Trans-perineal biopsy (TP-Bx) with a needle inserted directly through the skin to reach the prostate.

Typically, TP-BX is performed in the outpatient surgical setting due significant pain associated with the procedure, requiring the use anesthesia and/or sedation.

TP-Bx. procedure is very uncommon in the USA and is often performed using ultrasound alone (less accurate), without the benefit of MRI guided targeted biopsy.

Now, with the availability of new devices, we are able to perform both TR-Bx and TP-Bx using MRI/ultrasound fusion guided targeted approach, in the office setting, using local anesthesia alone.

With the TR-Bx, there has been increasing risk of infection related complications, sepsis and hospital admissions.

The newer approach of biopsy TP-Bx may cause fewer infections and may have a higher accuracy of finding cancer.

Using validated questionnaires such as IIEF-6, IPSS and TRUS-BxQ, this randomized study of

TR-BX and TP-Bx will address these questions:

  • Differences in the risk of infectious complications

  • Differences in the hemorrhagic and urinary side effects

  • Tolerability of both techniques with local anesthesia alone

  • Difference in the results of of MRI/US fusion targeted biopsy

  • Differences in the overall cancer detection rate and the high-grade cancer detection rate

  • Differences in the cost of the procedures

Study Design

Study Type:
Interventional
Anticipated Enrollment :
568 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized 1:1 to either trans-rectal needle biopsy (TR-Bx) or Trans-perineal biopsy (TP-Bx) of the prostate. Both arms, either with or without MRI guided biopsyRandomized 1:1 to either trans-rectal needle biopsy (TR-Bx) or Trans-perineal biopsy (TP-Bx) of the prostate. Both arms, either with or without MRI guided biopsy
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)
Actual Study Start Date :
Sep 9, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Systematic Transrectal biopsy (TR-Bx)

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

Procedure: Systematic Transrectal biopsy (TR-Bx)
Through the rectum
Other Names:
  • ultrasound guided

    		•
    Active Comparator: Targeted Transrectal biopsy (TR-Bx)

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

    Procedure: Targeted Transrectal biopsy (TR-Bx)
    Through the rectum
    Other Names:
  • MRI guided

    		•
    Experimental: Systematic Transperineal biopsy (TP-Bx)

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

    Procedure: Systematic Transperineal biopsy (TP-Bx)
    Through the perineal skin
    Other Names:
  • ultrasound guided

    		•
    Experimental: Targeted Transperineal biopsy (TP-Bx)

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

    Procedure: Targeted Transperineal biopsy (TP-Bx)
    Through the perineal skin
    Other Names:
  • MRI guided

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of infectious complications [30 days]

      Whether or not patient had an infection after the biopsy

    2. Rate of Bleeding complications [30 days]

      The type of bleeding and its severity (blood in urine or stool)

    Secondary Outcome Measures

    1. Cancer detection rate [30 days]

      The number of cancers and type (grade) of cancers detected in each study arm

    2. Tolerability under local anesthesia [30 days]

      Pain scores; Need for additional analgesia

    3. Patient reported urinary function measures using IPSS questionaire [30 days]

      International Prostate Symptoms Score (IPSS) to measure urinary function

    4. Cost of the procedures [30 days]

      Differences in the actual cost of the procedures (including supplies, time)

    5. Patient reported sexual function measures using IIEF questionaire [30 days]

      International Index of Erectile Function (IIEF) to measure sexual dysfunction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care

    • Either with or without an MRI

    Exclusion Criteria:

    • Patients with no access to rectum (due to previous rectal surgery)

    • Any abnormalities of the perineal skin (e.g. infection)

    • Patients whose procedure requires sedation or general anesthesia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Albany Medical College Albany New York United States 12208

    Sponsors and Collaborators

    • Albany Medical College

    Investigators

    • Principal Investigator: Badar M Mian, MD, Albany Medical College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Badar M. Mian, Professor of Surgery, Albany Medical College
    ClinicalTrials.gov Identifier:
    NCT04081636
    Other Study ID Numbers:
    • 5479
    First Posted:
    Sep 9, 2019
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Badar M. Mian, Professor of Surgery, Albany Medical College
    Prostate biopsy
    PSA
    infection
    bleeding
    Additional relevant MeSH terms:
    Infections

    Study Results

    No Results Posted as of Jun 16, 2022