Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 7/28/2018 |
| Start Date: | July 25, 2017 |
| End Date: | April 12, 2018 |
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.
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.
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 mpMRI+, arm A mpMRI-, and arm B and (2) Comparison of complication
rates between arm A mpMRI+ and arm B.
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 mpMRI+, arm A mpMRI-, and arm B and (2) Comparison of complication
rates between arm A mpMRI+ and arm B.
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
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