Prostate Biopsy: Reducing Complications and Improving Efficacy (ProBE-PC Randomized Trial)

Prostate Biopsy: Efficacy and Complications

Sponsors

Lead sponsor: Albany Medical College

Source Albany Medical College
Brief Summary

This study evaluates the difference between 2 prostate biopsy methods. Half of the subjects will have the prostate biopsy method using a needle through the rectum and the other half will have the biopsy method using a needle through the skin to reach the prostate.This research study hopes to scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.

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.

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

Previously, TP-BX was usually only performed in the outpatient surgical setting. Now we are able to perform these in the office.

Both of these biopsy methods are considered standard medical care in the United States.

With the TR-Bx, there has been increasing risk of infections and hospital admissions noted throughout the United States. The newer approach of biopsy TP-Bx may cause fewer infections and may have a higher accuracy of finding cancer.

The hypothesis of the study is that Office-based transperineal prostate biopsy will have a lower rate of infectious complications and increased cancer detection when compared to transrectal biopsy.

Overall Status Recruiting
Start Date June 20, 2019
Completion Date December 2021
Primary Completion Date December 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of infectious complications 30 days
Rate of Bleeding complications 30 days
Secondary Outcome
Measure Time Frame
Cancer detection rate 30 days
Enrollment 568
Condition
Intervention

Intervention type: Procedure

Intervention name: Transrectal biopsy (TR-Bx)

Description: through the rectum

Arm group label: Transrectal biopsy (TR-Bx)

Intervention type: Procedure

Intervention name: Transperineal biopsy (TP-Bx)

Description: Through the skin

Arm group label: Transperineal biopsy (TP-Bx)

Eligibility

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Patients with anatomic variations

- 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

- Patients who are scheduled to undergo "limited" sampling (usually 2-3 core needle samples) due to the following reasons:

- Patients who are unable to temporarily stop anticoagulation medications

- Immunocompromised patients who are at increased risk of infection

- Physician preference (e.g. older age; low risk of having cancer)

Gender: Male

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Badar M Mian, MD Principal Investigator Albany Medical College
Overall Contact

Last name: Brenda Romeo, CCRC

Phone: 518-262-8579

Email: [email protected]

Location
facility status contact investigator
Albany Medical College Recruiting Brenda Romeo, CCRC Hugh fisher, MD Sub-Investigator Ashar Ata, PhD Sub-Investigator
Location Countries

United States

Verification Date

September 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Albany Medical College

Investigator full name: Badar Mian

Investigator title: Professor of Surgery

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Transrectal biopsy (TR-Bx)

Arm group type: Active Comparator

Description: needle inserted through a probe in the rectum to reach the prostate

Arm group label: Transperineal biopsy (TP-Bx)

Arm group type: Experimental

Description: needle inserted directly through the skin to reach the prostate

Acronym ProBE-PC
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: 1:1 trans-rectal needle biopsy (TR-Bx) or Trans-perineal biopsy (TP-Bx) of the prostate

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov