Transperineal for Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
InfectionTransrectal MRI-guided prostate biopsy - Procedure
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial will compare the rate of infection and other complications after in-office transperineal MRI targeted prostate biopsy to the standard transrectal MRI targeted prostate biopsy.

Eligible Conditions
  • Infection

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 7 days post-biopsy

7 days post-biopsy
Detection of clinically significant disease as measured by Gleason Grade Group ≥ 2
Day 7
Change in adverse events, as measured on TRUS-BxQ
Change in infection adverse events, as measured on TRUS-BxQ
Day 7
Change in patient-reported anxiety, as measured on a 0-10 Likert scale
Change in patient-reported pain and discomfort, as measured on a 0-10 Likert scale

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Transperineal
1 of 2
Transrectal
1 of 2

Active Control

1302 Total Participants · 2 Treatment Groups

Primary Treatment: Transperineal · No Placebo Group · N/A

Transperineal
Procedure
ActiveComparator Group · 1 Intervention: Transperineal MRI-guided prostate biopsy · Intervention Types: Procedure
TransrectalActiveComparator Group · 2 Interventions: Transrectal MRI-guided prostate biopsy, Antibiotic (prophylaxis) · Intervention Types: Procedure, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days post-biopsy

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
989 Previous Clinical Trials
1,337,629 Total Patients Enrolled
2 Trials studying Infection
1,000 Patients Enrolled for Infection
Patient-Centered Outcomes Research InstituteOTHER
493 Previous Clinical Trials
29,828,893 Total Patients Enrolled
Jim C Hu, MD MPHPrincipal InvestigatorWeill Cornell Medicine, NewYork-Presbyterian
3 Previous Clinical Trials
1,003 Total Patients Enrolled
1 Trials studying Infection
400 Patients Enrolled for Infection

Eligibility Criteria

Age 18+ · Male Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to sign informed consent and adhere to the study protocol.
You have a history of prostate cancer, and you have a diagnostic biopsy preceding a confirmatory biopsy
Prior negative cohort: Clinical concern for the presence of prostate cancer as determined by the treating urologist and prior negative prostate biopsy performed ≤36 months prior to date of planned biopsy.