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NCT03632655

A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches

Terminated NA Results posted Last updated 31 May 2024
What this trial tests

NA trial testing prostate biopsy in Prostate Cancer in 38 participants. Terminated before completion.

Timeline
23 December 2017
Primary endpoint
8 October 2020
8 October 2020

Quick facts

Lead sponsorWeill Medical College of Cornell University
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment38
Start date23 December 2017
Primary completion8 October 2020
Estimated completion8 October 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Weill Medical College of Cornell University

Who can join

18 and older, male only, with Prostate Cancer or Elevated PSA. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Weill Medical College of Cornell University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03632655.

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