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

NCT03044197 | Completed Results DMC FDA Device

• 1 other identifier: 17-0013
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B

  Within 2-4 wks from biopsy

• Comparison of UTI Incidence in Arm A mpMRI+ and Arm B

  From the time of biopsy through 4 weeks post-biopsy

Study Arms (2)

MRI/ultrasound transperineal prostate biopsy

EXPERIMENTAL

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

transrectal ultrasound-guided prostate biopsy

ACTIVE COMPARATOR

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

Interventions

MRI/ultrasound transperineal prostate biopsy DEVICE

3-6 targeted biopsy cores from each prostate region of interest

MRI/ultrasound transperineal prostate biopsy

transrectal ultrasound-guided prostate biopsy DEVICE

12 systematic biopsy cores

transrectal ultrasound-guided prostate biopsy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged 18-75 years old
• PSA \>1 ng/ml but \<15 ng/ml
• Negative DRE
• Signed informed consent

You may not qualify if:

• Previous prostate biopsy or prostate surgery
• Previous prostate mpMRI
• Contraindication to mpMRI: patients with pacemakers, defibrillators or other implanted electronic devices
• Patients in the Texas Department of Criminal Justice (prisoners)
• Patients with acute urinary symptoms including urinary retention and urinary tract infection

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• 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.

  PMID: 29569311 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Erythema Multiforme

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Erythema; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous

Results Point of Contact

• Title: Lori Simon
• Organization: UTexasGalveston

lasimon@utmb.edu

409-772-1978

Study Officials

• Stephen B Williams, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: July 25, 2017
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: June 5, 2019
• Results First Posted: May 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)