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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044197
• Other study ID #: 17-0013
• Status: Completed
• Phase: N/A
• Start date: July 25, 2017
• Est. completion date: April 12, 2018

Study information

• Verified date: April 2019
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 12, 2018
• Est. primary completion date: April 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinically Significant Prostate Cancer
• Erythema Multiforme
• Fusion Biopsy
• Magnetic Resonance Imaging
• Prostate Cancer
• Prostatic Neoplasms
• Target Lesion
• Transperineal

Intervention

Device:
• MRI/ultrasound transperineal prostate biopsy
3-6 targeted biopsy cores from each prostate region of interest
• transrectal ultrasound-guided prostate biopsy
12 systematic biopsy cores

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch at Galveston	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinically Significant Prostate Cancer	Number of subjects with positive clinically significant prostate cancer results	Within 2-4 wks after biopsy
Secondary	Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B	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
Secondary	Comparison of UTI Incidence in Arm A mpMRI+ and Arm B	Number of confirmed UTIs	From the time of biopsy through 4 weeks post-biopsy