Trial Outcomes & Findings for Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer (NCT NCT02079025)
NCT ID: NCT02079025
Last Updated: 2019-02-26
Results Overview
Pathology analysis of prostate biopsy is reviewed for indication of clinically significant prostate cancer. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients.
COMPLETED
NA
1676 participants
First visit (a patient's involvement in the trial is complete following his biopsy).
2019-02-26
Participant Flow
Participant milestones
| Measure |
LR-TRUS
Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)
Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system
|
UHR-TRUS
Ultra-high resolution transrectal ultrasound guided prostate biopsy
High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
|
|---|---|---|
|
Overall Study
STARTED
|
839
|
837
|
|
Overall Study
COMPLETED
|
839
|
837
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
LR-TRUS
n=839 Participants
Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)
Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system
|
UHR-TRUS
n=837 Participants
Ultra-high resolution transrectal ultrasound guided prostate biopsy
High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
|
Total
n=1676 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 8.67 • n=839 Participants
|
62.7 years
STANDARD_DEVIATION 8.66 • n=837 Participants
|
62.7 years
STANDARD_DEVIATION 8.66 • n=1676 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=839 Participants
|
0 Participants
n=837 Participants
|
0 Participants
n=1676 Participants
|
|
Sex: Female, Male
Male
|
839 Participants
n=839 Participants
|
837 Participants
n=837 Participants
|
1676 Participants
n=1676 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
279 participants
n=839 Participants
|
272 participants
n=837 Participants
|
551 participants
n=1676 Participants
|
|
Region of Enrollment
United States
|
560 participants
n=839 Participants
|
565 participants
n=837 Participants
|
1125 participants
n=1676 Participants
|
PRIMARY outcome
Timeframe: First visit (a patient's involvement in the trial is complete following his biopsy).Population: Intent To Treat includes all subjects, Per Protocol includes only subjects without protocol deviations.
Pathology analysis of prostate biopsy is reviewed for indication of clinically significant prostate cancer. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients.
Outcome measures
| Measure |
LR-TRUS
n=839 Participants
Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)
Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system
|
UHR-TRUS
n=837 Participants
Ultra-high resolution transrectal ultrasound guided prostate biopsy
High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
|
|---|---|---|
|
Percentage of Participants With Clinically Significant Prostate Cancer
Intent to Treat
|
36.6 percentage of participants with csPCa
|
34.6 percentage of participants with csPCa
|
|
Percentage of Participants With Clinically Significant Prostate Cancer
Per Protocol
|
36.6 percentage of participants with csPCa
|
43.7 percentage of participants with csPCa
|
SECONDARY outcome
Timeframe: Pre-training refers to all biopsy procedures occurring between initial training and mid-trial PRI-MUS training. Post-training refers to all biopsy procedures performed after mid-trial PRI-MUS training.Population: Pre and post-training detection rate for csPCa for the UHR-TRUS arm only (as investigators received additional training on this imaging modality)
Comparison of pre- and post-training percentage of participants found to harbor clinically significant prostate cancer within the UHR-TRUS arm of the trial
Outcome measures
| Measure |
LR-TRUS
n=837 Participants
Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)
Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system
|
UHR-TRUS
Ultra-high resolution transrectal ultrasound guided prostate biopsy
High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
|
|---|---|---|
|
Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training
Post-Training
|
39.0 Percentage of subjects with csPCa
|
—
|
|
Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training
Pre-Training
|
32.4 Percentage of subjects with csPCa
|
—
|
SECONDARY outcome
Timeframe: First visit (a patient's involvement in the trial is complete following his biopsy).Pathology analysis of prostate biopsy is reviewed. Sensitivity of targeted biopsy for each arm will be calculated as the number of targeted biopsy that also found cancer among all targeted biopsies. Specificity of targeted biopsy for each arm will be calculated as the number of non-targeted biopsies that find no cancer among all non-targeted biopsies. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients.
Outcome measures
| Measure |
LR-TRUS
n=3372 Post-training biopsy samples
Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)
Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system
|
UHR-TRUS
n=3384 Post-training biopsy samples
Ultra-high resolution transrectal ultrasound guided prostate biopsy
High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
|
|---|---|---|
|
Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy
Sensitivity
|
38.0 percentage of post-training samples
|
60.8 percentage of post-training samples
|
|
Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy
Specificity
|
89.5 percentage of post-training samples
|
63.2 percentage of post-training samples
|
Adverse Events
LR-TRUS
UHR-TRUS
Serious adverse events
| Measure |
LR-TRUS
n=839 participants at risk
Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)
Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system
|
UHR-TRUS
n=837 participants at risk
Ultra-high resolution transrectal ultrasound guided prostate biopsy
High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
|
|---|---|---|
|
Infections and infestations
post-biopsy bacteremia
|
0.36%
3/839 • Number of events 3
|
0.36%
3/837 • Number of events 3
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place