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NCT03632655 · ClinicalTrials.gov registry record · NA
A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches
A NA study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT03632655 is a NA study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 38 participants.
The verdict
NCT03632655, a NA study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Primary endpoints will be pain as well as detection of clinically significant disease (defined as Gleason Score \>=7 or cancer core length \>=6 mm). Secondary endpoints will be detection of any prostate cancer, hospital re-admissions within 30 days, aborted procedures due to discomfort, procedure time, adverse events including hematuria, urinary retention, hematospermia, hematochezia, and infection, and patient-reported outcomes as measured on validated instruments such as International Prostate Symptom Scores (IPSS) and International Index of Erectile Function (IIEF-5). In men who subsequently elect to undergo radical prostatectomy for definitive treatment of their prostate cancer, Gleason scores at final pathology will be correlated to the Gleason scores obtained at time of biopsy.
Interventions
- PROCEDURE prostate biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-12-23 |
| Est. Completion | 2020-10-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03632655
The ClinicalTrials.gov registry entry for NCT03632655 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which prostate biopsy is the first listed.
NCT03632655 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03632655 about?
NCT03632655 is a clinical study titled "A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches". This randomized trial will compare the safety and efficacy of TPM versus TRUS biopsies performed in the outpatient setting. Primary endpoints will be pain as well as detection of clinically significant disease (defined as Gleason Score \>=7 or cancer core length \>=6 mm). Secondary endpoints will be...
What is the current status of trial NCT03632655?
This trial is currently terminated. It is a NA study. The enrollment target is 38 participants. The study started on 2017-12-23. Estimated completion is 2020-10-08.
What interventions are being tested in trial NCT03632655?
The interventions under investigation include: prostate biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03632655?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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