Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy

May 22, 2019 updated by: The University of Texas Medical Branch, Galveston

Assessing the Detection of Clinically Significant Prostate Cancer Using Magnetic Resonance Imaging-Guided Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy Outcomes Study: The ASTROS Trial

Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of increasing the detection of detecting clinically significant prostate cancer (csPCa) while decreasing the detection of non-significant PCa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound fusion-guided biopsy improves the detection rates of clinically significant prostate cancers (csPCa) compared with systematic transrectal ultrasound-guided prostate biopsy.

Patients who fulfill all eligibility criteria and have provided written consent will be randomized to undergo MRI followed by biopsies (arm A) or TRUS transrectal biopsy (arm-B). Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list. The primary end point will be the comparison of detection rates csPCa between arm A and arm B. csPCa will be defined according to the Standards of Reporting for MRI-targeted Biopsy Studies (START) criteria for targeted biopsy Gleason Score ≥ 7 or maximum CCL ≥ 5 mm and the updated Epstein criteria for SB (Gleason score ≥ 7, PSA density ≥ 0.15, Gleason score ≥ 2 positive cores, and bilateral cancer). The secondary end points will be (1) Comparison of the overall detection rate of PCa and csPCa between arm A mpMRI+ and arm B and (2) Comparison of complication rates between arm A mpMRI+ and arm B.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch at Galveston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Males aged 18-75 years old
  2. PSA >1 ng/ml but <15 ng/ml
  3. Negative DRE
  4. Signed informed consent

Exclusion Criteria:

  1. Previous prostate biopsy or prostate surgery
  2. Previous prostate mpMRI
  3. Contraindication to mpMRI: patients with pacemakers, defibrillators or other implanted electronic devices
  4. Patients in the Texas Department of Criminal Justice (prisoners)
  5. Patients with acute urinary symptoms including urinary retention and urinary tract infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MRI/ultrasound transperineal prostate biopsy
In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.
Device: MRI/ultrasound transperineal prostate biopsy
3-6 targeted biopsy cores from each prostate region of interest
ACTIVE_COMPARATOR: transrectal ultrasound-guided prostate biopsy
TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.
Device: transrectal ultrasound-guided prostate biopsy
12 systematic biopsy cores

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinically Significant Prostate Cancer
Time Frame: Within 2-4 wks after biopsy
Number of subjects with positive clinically significant prostate cancer results
Within 2-4 wks after biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B
Time Frame: Within 2-4 wks from biopsy
Number of overall positive prostate cancer (Combined positive and clinically significant positive results) Not all positive prostate biopsies are considered clinically significant. Clinically significant results indicate further work up and/or treatment. Physicians and patients may choose not to just monitor non-clinically significant prostate results for future changes. The overall detection rate will report the total number of both non-clinically significant positive results and clinically significant results.
Within 2-4 wks from biopsy
Comparison of UTI Incidence in Arm A mpMRI+ and Arm B
Time Frame: From the time of biopsy through 4 weeks post-biopsy
Number of confirmed UTIs
From the time of biopsy through 4 weeks post-biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Stephen B Williams, MD, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (ACTUAL)

July 25, 2017

Primary Completion (ACTUAL)

April 12, 2018

Study Completion (ACTUAL)

April 12, 2018

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (ESTIMATE)

February 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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