Trial Outcomes & Findings for Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI (NCT NCT05220501)
NCT ID: NCT05220501
Last Updated: 2025-11-10
Results Overview
As per protocol, the microultrasonography group for the primary outcome is defined as the microultrasonography-guided biopsy group and the blinded portion (microultrasound targets are identified prior to the unblinding of the MRI targets identified in the microultrasonography/mpMRI group). Difference in the detection rate of clinically significant prostate cancer (defined as equal to Gleason Grade Group 2 or higher) found using microultrasonography-guided biopsy, including targeted and systematic samples from the microultrasonography group and the mpMRI-blinded portion of the microultrasonography/mpMRI group, versus mpMRI/conventional ultrasonography-guided biopsy, including targeted and systematic samples from the mpMRI/conventional ultrasonography group.
COMPLETED
NA
804 participants
Post biopsy
2025-11-10
Participant Flow
Enrollment opened Dec 2021. Study closed September 6, 2024 after interim analysis endpoints were met for primary outcome. 804 participants recruited, 802 patients randomized. 2 participants withdrew consent prior to randomization. 678 participants were biopsied from 20 centres (hospital and clinics).
Assignment done at point of enrollment
Participant milestones
| Measure |
Microultrasonography
Participants received microultrasonography-guided targeted biopsy and systematic sampling
|
Microultrasonography/MRI
Participants received microultrasonography/mpMRI-fusion guided targeted biopsy and systematic sampling
|
MRI/conventional ultrasonography
Participants received mpMRI/conventional ultrasonography guided targeted biopsy and systematic sampling
|
|---|---|---|---|
|
Overall Study
STARTED
|
137
|
263
|
402
|
|
Overall Study
COMPLETED
|
121
|
226
|
331
|
|
Overall Study
NOT COMPLETED
|
16
|
37
|
71
|
Reasons for withdrawal
| Measure |
Microultrasonography
Participants received microultrasonography-guided targeted biopsy and systematic sampling
|
Microultrasonography/MRI
Participants received microultrasonography/mpMRI-fusion guided targeted biopsy and systematic sampling
|
MRI/conventional ultrasonography
Participants received mpMRI/conventional ultrasonography guided targeted biopsy and systematic sampling
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
21
|
32
|
|
Overall Study
Awaiting biopsy at time of interim analysis. Study closed. Primary endpoint met
|
5
|
16
|
39
|
Baseline Characteristics
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI
Baseline characteristics by cohort
| Measure |
Microultrasonography
n=121 Participants
Participants received microultrasonography-guided targeted biopsy and systematic sampling
|
Microultrasonography/MRI
n=226 Participants
Participants received microultrasonography/MRI-fusion guided targeted biopsy and systematic sampling
|
MRI/Conventional Ultrasonography
n=331 Participants
Participants received MRI/conventional ultrasonography guided targeted biopsy and systematic sampling
|
Total
n=678 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
100 Participants
n=20 Participants
|
161 Participants
n=40 Participants
|
316 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
66 Participants
n=5 Participants
|
126 Participants
n=20 Participants
|
170 Participants
n=40 Participants
|
362 Participants
n=28 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
226 Participants
n=20 Participants
|
331 Participants
n=40 Participants
|
678 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
African descent
|
3 Participants
n=5 Participants
|
8 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
27 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Asian descent
|
3 Participants
n=5 Participants
|
9 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
25 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Caucasian descent
|
105 Participants
n=5 Participants
|
180 Participants
n=20 Participants
|
277 Participants
n=40 Participants
|
562 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Hispanic descent
|
9 Participants
n=5 Participants
|
20 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
44 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Not stated/not reported
|
1 Participants
n=5 Participants
|
9 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
20 Participants
n=28 Participants
|
|
PSA (Prostate Specific Antigen)
|
7.2 ng/ml
n=5 Participants
|
7.0 ng/ml
n=20 Participants
|
6.7 ng/ml
n=40 Participants
|
6.8 ng/ml
n=28 Participants
|
|
Digital Rectal Exam (DRE)
|
25 Participants
n=5 Participants
|
48 Participants
n=20 Participants
|
81 Participants
n=40 Participants
|
154 Participants
n=28 Participants
|
|
Positive family history for prostate cancer
|
29 Participants
n=5 Participants
|
55 Participants
n=20 Participants
|
78 Participants
n=40 Participants
|
162 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Post biopsyPopulation: As per protocol, the rate of clinically significant prostate cancer found, was compared between participants who underwent microultrasonography (57 of 121 from microultrasonography group and 103 of 226 from the MRI blinded portion of the microultrasonography/mpMRI group) from those participants who underwent mpMRI/conventional ultrasonography-guided biopsy.
As per protocol, the microultrasonography group for the primary outcome is defined as the microultrasonography-guided biopsy group and the blinded portion (microultrasound targets are identified prior to the unblinding of the MRI targets identified in the microultrasonography/mpMRI group). Difference in the detection rate of clinically significant prostate cancer (defined as equal to Gleason Grade Group 2 or higher) found using microultrasonography-guided biopsy, including targeted and systematic samples from the microultrasonography group and the mpMRI-blinded portion of the microultrasonography/mpMRI group, versus mpMRI/conventional ultrasonography-guided biopsy, including targeted and systematic samples from the mpMRI/conventional ultrasonography group.
Outcome measures
| Measure |
Microultrasonography/MRI
n=347 Participants
MicroUS/mpMRI ultrasonography guided Biopsy with synchronous systematic biopsy
|
MRI/ conventional ultrasonography
n=331 Participants
mpMRI/conventional ultrasonography guided Biopsy with synchronous systematic biopsy
|
|---|---|---|
|
Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy
|
160 Participants
|
141 Participants
|
SECONDARY outcome
Timeframe: Immediately after biopsyThe secondary outcome, detection of clinically significant prostate cancer by combined microultrasonography/mpMRI-guided fusion biopsy vs mpMRI/conventional ultrasonography-guided fusion biopsy.
Outcome measures
| Measure |
Microultrasonography/MRI
n=226 Participants
MicroUS/mpMRI ultrasonography guided Biopsy with synchronous systematic biopsy
|
MRI/ conventional ultrasonography
n=331 Participants
mpMRI/conventional ultrasonography guided Biopsy with synchronous systematic biopsy
|
|---|---|---|
|
Difference in csPCa Rate Between MicroUS/MRI- Guided Fusion Biopsy and MRI/Conventional Ultrasonography Guided Fusion Biopsy
|
106 Participants
|
141 Participants
|
Adverse Events
Microultrasonography
Microultrasonography/MRI
MRI/conventional ultrasonography
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Microultrasonography
n=121 participants at risk
Participants received microultrasonography-guided targeted biopsy and systematic sampling
|
Microultrasonography/MRI
n=226 participants at risk
Participants received microultrasonography-guided targeted biopsy and systematic sampling
|
MRI/conventional ultrasonography
n=331 participants at risk
Participants received MRI/conventional ultrasonography guided targeted biopsy and systematic sampling
|
|---|---|---|---|
|
Surgical and medical procedures
Infection
|
0.00%
0/121 • 7-days post biopsy
|
0.00%
0/226 • 7-days post biopsy
|
0.91%
3/331 • Number of events 3 • 7-days post biopsy
|
|
Renal and urinary disorders
Urinary Tract Disorders
|
0.00%
0/121 • 7-days post biopsy
|
0.44%
1/226 • Number of events 1 • 7-days post biopsy
|
1.5%
5/331 • Number of events 5 • 7-days post biopsy
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/121 • 7-days post biopsy
|
0.00%
0/226 • 7-days post biopsy
|
0.30%
1/331 • Number of events 1 • 7-days post biopsy
|
Additional Information
Dr. Laurence Klotz
Sunnybrook Health Sciences Centre
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60