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

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ClinicalTrials.gov Identifier: NCT03044197
Recruitment Status : Completed
First Posted : February 6, 2017
Results First Posted : May 9, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Magnetic Resonance Imaging Target Lesion Fusion Biopsy Clinically Significant Prostate Cancer Transperineal Device: MRI/ultrasound transperineal prostate biopsy Device: transrectal ultrasound-guided prostate biopsy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : April 12, 2018
Actual Study Completion Date : April 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI/ultrasound transperineal prostate biopsy
In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.
Device: MRI/ultrasound transperineal prostate biopsy
3-6 targeted biopsy cores from each prostate region of interest

Active Comparator: transrectal ultrasound-guided prostate biopsy
TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.
Device: transrectal ultrasound-guided prostate biopsy
12 systematic biopsy cores




Primary Outcome Measures :
  1. Number of Participants With Clinically Significant Prostate Cancer [ Time Frame: Within 2-4 wks after biopsy ]
    Number of subjects with positive clinically significant prostate cancer results


Secondary Outcome Measures :
  1. Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B [ Time Frame: Within 2-4 wks from biopsy ]
    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.

  2. Comparison of UTI Incidence in Arm A mpMRI+ and Arm B [ Time Frame: From the time of biopsy through 4 weeks post-biopsy ]
    Number of confirmed UTIs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044197


Locations
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United States, Texas
The University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Stephen B Williams, MD University of Texas
  Study Documents (Full-Text)

Documents provided by The University of Texas Medical Branch, Galveston:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03044197     History of Changes
Other Study ID Numbers: 17-0013
First Posted: February 6, 2017    Key Record Dates
Results First Posted: May 9, 2019
Last Update Posted: June 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The University of Texas Medical Branch, Galveston:
prostate cancer
magnetic resonance imaging
transperineal biopsy
target lesion
fusion biopsy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Erythema Multiforme
Genital Diseases, Male
Erythema
Skin Diseases
Skin Diseases, Vesiculobullous