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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Prostate Cancer
Magnetic Resonance Imaging
Target Lesion
Fusion Biopsy
Clinically Significant Prostate Cancer
Transperineal
Interventions Device: MRI/ultrasound transperineal prostate biopsy
Device: transrectal ultrasound-guided prostate biopsy
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MRI/Ultrasound Transperineal Prostate Biopsy Transrectal Ultrasound-guided Prostate Biopsy
Hide Arm/Group Description

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.

MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest

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.

transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores

Period Title: Overall Study
Started 12 12
Completed 9 11
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             3             1
Arm/Group Title MRI/Ultrasound Transperineal Prostate Biopsy Transrectal Ultrasound-guided Prostate Biopsy Total
Hide Arm/Group Description

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.

MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest

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.

transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores

Total of all reporting groups
Overall Number of Baseline Participants 9 11 20
Hide Baseline Analysis Population Description
3 subjects in Arm A and 1 subject in Arm B withdrew from the study.
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 11 participants 20 participants
64
(56 to 71)
60
(54 to 68)
62
(54 to 71)
[1]
Measure Analysis Population Description: 3 subjects in Arm A and 1 subject in Arm B withdrew from the study.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
9
 100.0%
11
 100.0%
20
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
9
 100.0%
11
 100.0%
20
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  11.1%
1
   9.1%
2
  10.0%
White
8
  88.9%
10
  90.9%
18
  90.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 11 participants 20 participants
9 11 20
1.Primary Outcome
Title Number of Participants With Clinically Significant Prostate Cancer
Time Frame Within 2-4 wks after biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MRI/Ultrasound Transperineal Prostate Biopsy Transrectal Ultrasound-guided Prostate Biopsy
Hide Arm/Group Description:

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.

MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest

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.

transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores

Overall Number of Participants Analyzed 9 11
Measure Type: Count of Participants
Unit of Measure: Participants
6
  66.7%
6
  54.5%
2.Secondary Outcome
Title Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B
Hide Description 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.
Time Frame Within 2-4 wks from biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MRI/Ultrasound Transperineal Prostate Biopsy Transrectal Ultrasound-guided Prostate Biopsy
Hide Arm/Group Description:

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.

MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest

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.

transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores

Overall Number of Participants Analyzed 9 11
Measure Type: Count of Participants
Unit of Measure: Participants
8
  88.9%
7
  63.6%
3.Secondary Outcome
Title Comparison of UTI Incidence in Arm A mpMRI+ and Arm B
Hide Description Number of confirmed UTIs
Time Frame From the time of biopsy through 4 weeks post-biopsy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MRI/Ultrasound Transperineal Prostate Biopsy Transrectal Ultrasound-guided Prostate Biopsy
Hide Arm/Group Description:

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.

MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest

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.

transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores

Overall Number of Participants Analyzed 9 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Time of biopsy through 2 to 4 weeks post biopsy
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MRI/Ultrasound Transperineal Prostate Biopsy Transrectal Ultrasound-guided Prostate Biopsy
Hide Arm/Group Description

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.

MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest

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.

transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores

All-Cause Mortality
MRI/Ultrasound Transperineal Prostate Biopsy Transrectal Ultrasound-guided Prostate Biopsy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
MRI/Ultrasound Transperineal Prostate Biopsy Transrectal Ultrasound-guided Prostate Biopsy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MRI/Ultrasound Transperineal Prostate Biopsy Transrectal Ultrasound-guided Prostate Biopsy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Lori Simon
Organization: UTexasGalveston
Phone: 409-772-1978
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03044197     History of Changes
Other Study ID Numbers: 17-0013
First Submitted: February 2, 2017
First Posted: February 6, 2017
Results First Submitted: April 18, 2019
Results First Posted: May 9, 2019
Last Update Posted: June 5, 2019