Trial Outcomes & Findings for PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy (NCT NCT04843566)

Last Updated: 2025-04-15

Results Overview

Outcome measure Description Now says: Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaires that reported infection complications and duration of symptoms, had their electronic medical records verified to confirm if an infection occurred or not.

Recruitment status

COMPLETED

Study phase

Target enrollment

687 participants

Primary outcome timeframe

7 days post-biopsy

Results posted on

2025-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Transrectal Patients will receive a transrectal MRI-guided prostate biopsy. Transrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. Antibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.	Transperineal Patients will receive a transperineal MRI-guided prostate biopsy. Transperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Overall Study STARTED	342	345
Overall Study Intent To Treat (Underwent Non-assigned Intervention)	17	12
Overall Study COMPLETED	259	282
Overall Study NOT COMPLETED	83	63

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transrectal n=342 Participants Patients will receive a transrectal MRI-guided prostate biopsy. Transrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. Antibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.	Transperineal n=345 Participants Patients will receive a transperineal MRI-guided prostate biopsy. Transperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.	Total n=687 Participants Total of all reporting groups
Age, Customized	66 years n=5 Participants	66 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	342 Participants n=5 Participants	345 Participants n=7 Participants	687 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	44 Participants n=5 Participants	32 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) White	168 Participants n=5 Participants	189 Participants n=7 Participants	357 Participants n=5 Participants
Race (NIH/OMB) More than one race	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	99 Participants n=5 Participants	95 Participants n=7 Participants	194 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic · Hispanic ethnicity	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic · Unknown	332 Participants n=5 Participants	334 Participants n=7 Participants	666 Participants n=5 Participants
Region of Enrollment United States	342 Participants n=5 Participants	345 Participants n=7 Participants	687 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days post-biopsy

Population: Subjects in the transrectal arm that underwent a transperineal biopsy or withdrew were excluded from analysis. Subjects in the transperineal arm that underwent a transrectal biopsy or withdrew were excluded from analysis.

Outcome measures

Outcome measures
Measure	Transrectal n=280 Participants Patients will receive a transrectal MRI-guided prostate biopsy. Transrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. Antibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.	Transperineal n=287 Participants Patients will receive a transperineal MRI-guided prostate biopsy. Transperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Percentage of Subjects That Experienced Infection, Urinary Retention or Bleeding Requiring Intervention Within 7 Days of Biopsy Based on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) Infection	1.4 percentage of participants	0 percentage of participants
Percentage of Subjects That Experienced Infection, Urinary Retention or Bleeding Requiring Intervention Within 7 Days of Biopsy Based on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) Urinary Retention	1.1 percentage of participants	0.3 percentage of participants
Percentage of Subjects That Experienced Infection, Urinary Retention or Bleeding Requiring Intervention Within 7 Days of Biopsy Based on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) Bleeding requiring intervention	0.4 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Immediately following biopsy, 7 days post-biopsy

Patient reported pain via a yes/no questionnaire

Outcome measures

Outcome measures
Measure	Transrectal n=277 Participants Patients will receive a transrectal MRI-guided prostate biopsy. Transrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. Antibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.	Transperineal n=283 Participants Patients will receive a transperineal MRI-guided prostate biopsy. Transperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Percentage of Patient Reporting Biopsy Pain and Discomfort Immediately following biopsy - pain	3.0 percentage of participants	3.7 percentage of participants
Percentage of Patient Reporting Biopsy Pain and Discomfort Immediately following biopsy - discomfort	3.8 percentage of participants	4.2 percentage of participants
Percentage of Patient Reporting Biopsy Pain and Discomfort 7-day post biopsy - pain	3.6 percentage of participants	4.5 percentage of participants
Percentage of Patient Reporting Biopsy Pain and Discomfort 7-day post biopsy - discomfort	1.7 percentage of participants	2.0 percentage of participants

SECONDARY outcome

Timeframe: Immediately following biopsy

Anxiety will be scored on a 0-10 Likert scale. 0 indicates no anxiety and high scores indicate greater anxiety.

Outcome measures

Outcome measures
Measure	Transrectal n=279 Participants Patients will receive a transrectal MRI-guided prostate biopsy. Transrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. Antibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.	Transperineal n=286 Participants Patients will receive a transperineal MRI-guided prostate biopsy. Transperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Change in Patient-reported Anxiety, as Measured on a 0-10 Likert Scale	4.2 score on a scale Standard Deviation 2.9	3.9 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 7 days post-biopsy

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

Outcome measures
Measure	Transrectal n=280 Participants Patients will receive a transrectal MRI-guided prostate biopsy. Transrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. Antibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.	Transperineal n=287 Participants Patients will receive a transperineal MRI-guided prostate biopsy. Transperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2 Gleason grade group ≥ 2	141 Participants	151 Participants
Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2 Gleason grade group 1	62 Participants	49 Participants
Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2 No Gleason Score	77 Participants	87 Participants

SECONDARY outcome

Timeframe: 7 days post-biopsy

Transrectal Ultrasound Guided prostate Biopsy Questionnaire (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

Outcome measures
Measure	Transrectal n=280 Participants Patients will receive a transrectal MRI-guided prostate biopsy. Transrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. Antibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.	Transperineal n=287 Participants Patients will receive a transperineal MRI-guided prostate biopsy. Transperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Change in Adverse Events, as Measured on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) Infection	4 Participants	0 Participants
Change in Adverse Events, as Measured on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) Urinary Retention	3 Participants	1 Participants
Change in Adverse Events, as Measured on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) Bleeding requiring intervention	1 Participants	0 Participants

Adverse Events

Transrectal

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Transperineal

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Transrectal n=280 participants at risk Patients will receive a transrectal MRI-guided prostate biopsy. Transrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. Antibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.	Transperineal n=287 participants at risk Patients will receive a transperineal MRI-guided prostate biopsy. Transperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Renal and urinary disorders Urinary retention	1.1% 3/280 • Number of events 3 • 10 days post biopsy procedure date Only subjects that were included in the intent to treat analysis were evaluated for adverse events.	0.35% 1/287 • Number of events 1 • 10 days post biopsy procedure date Only subjects that were included in the intent to treat analysis were evaluated for adverse events.
Renal and urinary disorders Infection	1.4% 4/280 • Number of events 4 • 10 days post biopsy procedure date Only subjects that were included in the intent to treat analysis were evaluated for adverse events.	0.00% 0/287 • 10 days post biopsy procedure date Only subjects that were included in the intent to treat analysis were evaluated for adverse events.
Renal and urinary disorders Bleeding	0.36% 1/280 • Number of events 1 • 10 days post biopsy procedure date Only subjects that were included in the intent to treat analysis were evaluated for adverse events.	0.00% 0/287 • 10 days post biopsy procedure date Only subjects that were included in the intent to treat analysis were evaluated for adverse events.

Additional Information

Jim Hu

Weill Cornell Medicine

Phone: 2127463418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place