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
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
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: ProcedureTransrectalActiveComparator 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.
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Conditions
Cancer Related
Treatments