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NCT02364531: COSMiC

A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting

Completed Last updated 6 December 2019
What this trial tests

trial testing Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry in Prostatic Neoplasms in 194 participants. Completed in 1 November 2018.

Timeline
30 September 2014
Primary endpoint
1 November 2018
1 November 2018

Quick facts

Lead sponsorJanssen Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment194
Start date30 September 2014
Primary completion1 November 2018
Estimated completion1 November 2018
Sites41 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Janssen Inc. — full company profile →

Who can join

18 and older, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to temporally evaluate the impact of abiraterone acetate (ZYTIGA) therapy on Patient Reported Outcomes (PROs) and on clinical outcomes in the chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) population. Safety data, levels of health care resource utilization associated with abiraterone acetate (ZYTIGA) therapy will also be prospectively collected and analyzed.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Abiraterone acetate preferentially enriches for the gut commensal Akkermansia muciniphila in castrate-resistant prostate cancer patients.
    Daisley BA, Chanyi RM, Abdur-Rashid K, Al KF, et al · · 2020 · cited 102× · PMID 32973149 · DOI 10.1038/s41467-020-18649-5
  2. Real-world evidence in patient-reported outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate + prednisone (AA+P) across Canada: Final results of COSMiC.
    Gotto G, Drachenberg DE, Chin J, Casey R, et al · · 2020 · cited 10× · PMID 32569568 · DOI 10.5489/cuaj.6388
  3. Assessment and Management of Cognitive Function in Patients with Prostate Cancer Treated with Second-Generation Androgen Receptor Pathway Inhibitors.
    Wefel JS, Ryan CJ, Van J, Jackson JC, et al · · 2022 · cited 9× · PMID 35522374 · DOI 10.1007/s40263-022-00913-5
  4. 2018 CUA Abstracts.
    · 2018 · PMID 29877793
  5. Podium Session 1: Prostate Cancer June 26, 2016 1050–1150
    · 2016

Verify or expand the search:

Other recruiting trials for Prostatic Neoplasms

Currently open trials in the same condition.

Other Janssen Inc. 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/NCT02364531.

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