Clinical Trial: Discerning Detection of Clinically Significant Prostate Cancer Using Magnetic Resonance Imaging-Guided Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Discerning Detection of Clinically Significant Prostate Cancer Using Magnetic Resonance Imaging-Guided Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy

Brief Summary: 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. The goals and the objective of this study are as follows keeping this in mind.

Detailed Summary:

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 full-fills 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 MRI+ and arm A MRI-, (2) comparison in terms of pathologic results and (3) comparison of complication rates.


Sponsor: The University of Texas Medical Branch, Galveston

Current Primary Outcome: Detection rate of significant prostate cancers [ Time Frame: Within 2-4 wks from biopsy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall detection rate of PCa and csPCa between arm A MRI+ and arm A MRI- [ Time Frame: Within 2-4 wks from biopsy ]
  • Comparison in terms of pathologic results [ Time Frame: Within 2-4 wks from biopsy ]
  • Comparison of complication rates [ Time Frame: Within 2-4 wks from biopsy ]


Original Secondary Outcome: Same as current

Information By: The University of Texas Medical Branch, Galveston

Dates:
Date Received: February 2, 2017
Date Started: July 1, 2017
Date Completion: August 1, 2018
Last Updated: May 1, 2017
Last Verified: February 2017