Study Summary
This trial will compare the rates of infection, pain, and detection of prostate cancer between the two biopsy methods.
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 Transrectal Ultrasound Guided prostate Biopsy Questionnaire (TRUS-BxQ)
Biopsy
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
Transrectal
1 of 2
Transperineal
1 of 2
Active Control
400 Total Participants · 2 Treatment Groups
Primary Treatment: Transrectal · No Placebo Group · N/A
TransrectalActiveComparator Group · 2 Interventions: Antibiotic (prophylaxis), Transrectal MRI-guided prostate biopsy · Intervention Types: Drug, Procedure
Transperineal
Procedure
ActiveComparator Group · 1 Intervention: Transperineal MRI-guided prostate biopsy · Intervention Types: ProcedureTrial 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
1,338,531 Total Patients Enrolled
2 Trials studying Infection
1,902 Patients Enrolled for Infection
National Cancer Institute (NCI)NIH
13,086 Previous Clinical Trials
41,141,246 Total Patients Enrolled
21 Trials studying Infection
2,057 Patients Enrolled for Infection
Jim C Hu, MD MPHPrincipal InvestigatorWeill Cornell Medicine, NewYork-Presbyterian
3 Previous Clinical Trials
1,905 Total Patients Enrolled
1 Trials studying Infection
1,302 Patients Enrolled for Infection
Eligibility Criteria
Age 18+ · Male Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are a man without a previous prostate biopsy.
You are willing to sign informed consent and adhere to the study protocol.
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Conditions
Cancer Related
Treatments