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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: Clinical Trial NA study, sponsored by Weill Medical College of Cornell University.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Detection of clinically significant disease Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. * Scores of 6 or less describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly. * A score of 7 suggests and intermediate risk for aggressive cancer. Scoring a 7 means that the primary score (largest section of the tumor) scored a 3 or 4. Tumors with a primary score of 3
Interventions
- PROCEDURE prostate biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-12-23 |
| Est. Completion | 2020-10-08 |
| Phase | NA |
Why NCT03632655 stopped before completion
NCT03632655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which prostate biopsy is the first listed.
NCT03632655 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03632655's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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