Clinical trial NCT03044197: Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Magnetic Resonance Imaging
Target Lesion
Fusion Biopsy
Clinically Significant Prostate Cancer
Transperineal
Keywords: prostate cancer
magnetic resonance imaging
transperineal biopsy
target lesion
fusion biopsy
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Clinically Significant Prostate Cancer
timeFrame: Within 2-4 wks after biopsy
Secondary outcomes:
measure: Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B
timeFrame: Within 2-4 wks from biopsy
measure: Comparison of UTI Incidence in Arm A mpMRI+ and Arm B
timeFrame: From the time of biopsy through 4 weeks post-biopsy
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch at Galveston
state: Texas
Study officials:
affiliation: University of Texas
name: Stephen B Williams, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kosarek CD, Mahmoud AM, Eyzaguirre EJ, Shan Y, Walser EM, Horn GL, Williams SB. Initial series of magnetic resonance imaging (MRI)-fusion targeted prostate biopsy using the first transperineal targeted platform available in the USA. BJU Int. 2018 Nov;122(5):909-912. doi: 10.1111/bju.14206. Epub 2018 Apr 14.