Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications
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.
Conditions:
🦠 Prostate Cancer 🦠 PSA 🦠 Infection
🗓️ Study Start (Actual) 2 September 2019
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 840
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Albany, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 September 2019
  • First Submitted that Met QC Criteria 5 September 2019
  • First Posted 9 September 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 January 2024
  • Last Update Posted 30 January 2024
  • Last Verified January 2024