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NCT02813408: AQUARiUS

A Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Participant-Reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Participants

Completed Last updated 24 May 2019
What this trial tests

trial in Prostatic Neoplasms in 226 participants. Completed in 21 March 2018.

Timeline
3 May 2016
Primary endpoint
21 March 2018
21 March 2018

Quick facts

Lead sponsorJanssen Pharmaceutica N.V., Belgium
StatusCompleted
Study typeOBSERVATIONAL
Enrollment226
Start date3 May 2016
Primary completion21 March 2018
Estimated completion21 March 2018
Sites26 locations across Denmark, United Kingdom, France

Conditions studied

Sponsor

Janssen Pharmaceutica N.V., Belgium — 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 observational study of metastatic castration-resistant prostate cancer (mCRPC) participants is to explore whether or not there are differences between participants treated with abiraterone acetate and enzalutamide on the health-related quality of life (HRQoL), Fatigue, Pain, Cognitive function and medical resource use (MRU).

Publications & conference data

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

  1. Impact of Abiraterone Acetate plus Prednisone or Enzalutamide on Patient-reported Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer: Final 12-mo Analysis from the Observational AQUARiUS Study.
    Thiery-Vuillemin A, Poulsen MH, Lagneau E, Ploussard G, et al · · 2020 · cited 44× · PMID 31594705 · DOI 10.1016/j.eururo.2019.09.019
  2. Impact of abiraterone acetate plus prednisone or enzalutamide on fatigue and cognition in patients with metastatic castration-resistant prostate cancer: initial results from the observational AQUARiUS study.
    Thiery-Vuillemin A, Hvid Poulsen M, Lagneau E, Ploussard G, et al · · 2018 · cited 31× · PMID 30116592 · DOI 10.1136/esmoopen-2018-000397
  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. Impact of abiraterone on patient-related outcomes in metastatic castration-resistant prostate cancer: current perspectives.
    El-Amm J, Nassabein R, Aragon-Ching JB. · · 2017 · cited 4× · PMID 28744160 · DOI 10.2147/cmar.s139305

Verify or expand the search:

Other recruiting trials for Prostatic Neoplasms

Currently open trials in the same condition.

Other Janssen Pharmaceutica N.V., Belgium 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/NCT02813408.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing