NCT03044197

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Prostate Cancer
• Magnetic Resonance Imaging
• Target Lesion
• Fusion Biopsy
• Clinically Significant Prostate Cancer
• Transperineal

Interventions

Type	Name	Description
DEVICE	MRI/ultrasound transperineal prostate biopsy	3-6 targeted biopsy cores from each prostate region of interest
DEVICE	transrectal ultrasound-guided prostate biopsy	12 systematic biopsy cores

Timeline

• Start date: 2017-07-25
• Primary completion: 2018-04-12
• Completion: 2018-04-12
• First posted: 2017-02-06
• Last updated: 2019-06-05
• Results posted: 2019-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study