Trial Outcomes & Findings for PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2 (NCT NCT04815876)
NCT ID: NCT04815876
Last Updated: 2026-08-24
Results Overview
TRUS-BxQ is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaire consists of Yes/No questions about infection complications and duration of infection.
COMPLETED
NA
1040 participants
up to 7- 10 days post-biopsy
2026-08-24
Participant Flow
Participant milestones
| Measure |
Transrectal
Patients will receive a transrectal MRI-guided prostate biopsy.
|
Transperineal
Patients will receive a transperineal MRI-guided prostate biopsy.
|
|---|---|---|
|
Overall Study
STARTED
|
514
|
526
|
|
Overall Study
COMPLETED
|
477
|
486
|
|
Overall Study
NOT COMPLETED
|
37
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
Baseline characteristics by cohort
| Measure |
Transrectal
n=514 Participants
Patients will receive a transrectal MRI-guided prostate biopsy.
|
Transperineal
n=526 Participants
Patients will receive a transperineal MRI-guided prostate biopsy.
|
Total
n=1040 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
125 Participants
n=1541 Participants
|
136 Participants
n=1121 Participants
|
261 Participants
n=2662 Participants
|
|
Age, Categorical
>=65 years
|
389 Participants
n=1541 Participants
|
390 Participants
n=1121 Participants
|
779 Participants
n=2662 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Sex: Female, Male
Male
|
514 Participants
n=1541 Participants
|
526 Participants
n=1121 Participants
|
1040 Participants
n=2662 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=1541 Participants
|
19 Participants
n=1121 Participants
|
42 Participants
n=2662 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
411 Participants
n=1541 Participants
|
429 Participants
n=1121 Participants
|
840 Participants
n=2662 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
80 Participants
n=1541 Participants
|
78 Participants
n=1121 Participants
|
158 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=1541 Participants
|
1 Participants
n=1121 Participants
|
4 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=1541 Participants
|
21 Participants
n=1121 Participants
|
39 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1541 Participants
|
1 Participants
n=1121 Participants
|
1 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Black or African American
|
69 Participants
n=1541 Participants
|
76 Participants
n=1121 Participants
|
145 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
White
|
348 Participants
n=1541 Participants
|
337 Participants
n=1121 Participants
|
685 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1541 Participants
|
0 Participants
n=1121 Participants
|
0 Participants
n=2662 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
76 Participants
n=1541 Participants
|
90 Participants
n=1121 Participants
|
166 Participants
n=2662 Participants
|
PRIMARY outcome
Timeframe: up to 7- 10 days post-biopsyPopulation: The number of participants analyzed are those that were included in the intent to treat analysis.
TRUS-BxQ is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaire consists of Yes/No questions about infection complications and duration of infection.
Outcome measures
| Measure |
Transrectal
n=477 Participants
Patients will receive a transrectal MRI-guided prostate biopsy.
|
Transperineal
n=486 Participants
Patients will receive a transperineal MRI-guided prostate biopsy.
|
|---|---|---|
|
Number of Participants With Infection/Adverse Events, as Measured on the TRUS-Bx Questionnaire
infection
|
2 Participants
|
0 Participants
|
|
Number of Participants With Infection/Adverse Events, as Measured on the TRUS-Bx Questionnaire
no infection
|
475 Participants
|
486 Participants
|
SECONDARY outcome
Timeframe: Immediately following biopsy, 7 days post-biopsyPopulation: Participants are those that were included in the intent- to -treat analysis.
Pain and discomfort will be scored on a 0-10 Likert scale. 0 indicates no pain/discomfort and high scores indicate greater pain/discomfort.
Outcome measures
| Measure |
Transrectal
n=477 Participants
Patients will receive a transrectal MRI-guided prostate biopsy.
|
Transperineal
n=486 Participants
Patients will receive a transperineal MRI-guided prostate biopsy.
|
|---|---|---|
|
Change in Patient-reported Pain and Discomfort, as Measured on a 0-10 Likert Scale
Immediate post - biopsy Pain
|
3.2 score on a scale
Standard Deviation 2.4
|
3.8 score on a scale
Standard Deviation 2.6
|
|
Change in Patient-reported Pain and Discomfort, as Measured on a 0-10 Likert Scale
Immediate post- biopsy Discomfort
|
3.9 score on a scale
Standard Deviation 2.6
|
4.2 score on a scale
Standard Deviation 2.6
|
|
Change in Patient-reported Pain and Discomfort, as Measured on a 0-10 Likert Scale
7-Day Discomfort
|
1.7 score on a scale
Standard Deviation 2.3
|
1.9 score on a scale
Standard Deviation 2.3
|
|
Change in Patient-reported Pain and Discomfort, as Measured on a 0-10 Likert Scale
7-day Pain
|
33 score on a scale
Standard Deviation 8.3
|
64 score on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Immediately following biopsyPopulation: Participants that were included are those from the intent- to -treat analysis. There was no 7-day anxiety data collected.
Anxiety will be scored on a 0-10 Likert scale. 0 indicates no anxiety and high scores indicate greater anxiety.
Outcome measures
| Measure |
Transrectal
n=477 Participants
Patients will receive a transrectal MRI-guided prostate biopsy.
|
Transperineal
n=486 Participants
Patients will receive a transperineal MRI-guided prostate biopsy.
|
|---|---|---|
|
Change in Patient-reported Anxiety, as Measured on a 0-10 Likert Scale
|
3.4 score on a scale
Standard Deviation 2.9
|
3.8 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 7 days post-biopsyPopulation: Participants are from those included in the intent- to- treat analysis
Gleason Grade Group is a prostate cancer grading system released by the International Society of Urological Pathology (ISUP). Grade Group 1 indicates Low/Very Low Risk, Grade Group 2 indicates Intermediate (Favorable) Risk, Grade Group 3 indicates Intermediate (Unfavorable) Risk, and Grade Groups 4 and 5 indicate High/Very High Risk. Prostate cancer grade will be categorized into insignificant (Gleason Grade Group 1) and clinically significant (Grade Group ≥ 2).
Outcome measures
| Measure |
Transrectal
n=477 Participants
Patients will receive a transrectal MRI-guided prostate biopsy.
|
Transperineal
n=486 Participants
Patients will receive a transperineal MRI-guided prostate biopsy.
|
|---|---|---|
|
Number of Participants With Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2
GGG 1 (Low-Grade) Cancer Detection
|
175 participants
|
132 participants
|
|
Number of Participants With Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2
GGG ≥2 (Clinically Significant) Cancer Detection
|
171 participants
|
209 participants
|
SECONDARY outcome
Timeframe: up to 7-10 days post-biopsyPopulation: Participants are from those included in the intent- to -treat analysis.
TRUS-BxQ is a validated biopsy questionnaire that measures adverse events that have occurred, such as hospital re-admissions, aborted procedures due to discomfort, hematuria, urinary retention, hematospermia, and/or hematochezia. Patient questionnaire consists of Yes/No questions about general complications and duration of adverse events.
Outcome measures
| Measure |
Transrectal
n=477 Participants
Patients will receive a transrectal MRI-guided prostate biopsy.
|
Transperineal
n=486 Participants
Patients will receive a transperineal MRI-guided prostate biopsy.
|
|---|---|---|
|
Number of Adverse Events, as Measured on TRUS-BxQ
Bleeding Requiring Intervention (7- day post biopsy)
|
0 count of adverse events
|
0 count of adverse events
|
|
Number of Adverse Events, as Measured on TRUS-BxQ
Urinary Retention Requiring Intervention ( 7- day post biopsy)
|
2 count of adverse events
|
1 count of adverse events
|
Adverse Events
Transrectal
Transperineal
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transrectal
n=514 participants at risk
Patients will receive a transrectal MRI-guided prostate biopsy.
|
Transperineal
n=526 participants at risk
Patients will receive a transperineal MRI-guided prostate biopsy.
|
|---|---|---|
|
Renal and urinary disorders
Bleeding or urinary Retention that required intervention
|
0.39%
2/514 • Number of events 2 • From the date of Biopsy until 10 days post biopsy
|
0.19%
1/526 • Number of events 1 • From the date of Biopsy until 10 days post biopsy
|
|
Infections and infestations
Infection that required intervention
|
0.39%
2/514 • Number of events 2 • From the date of Biopsy until 10 days post biopsy
|
0.00%
0/526 • From the date of Biopsy until 10 days post biopsy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place