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
NCT ID: NCT02813408
Last Updated: 2019-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
226 participants
OBSERVATIONAL
2016-05-03
2018-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with Prostate Cancer (abiraterone acetate)
Participants with metastatic castration resistant prostate cancer (mCRPC) will receive abiraterone acetate at the discretion of his treating physician.
No interventions assigned to this group
Participants with Prostate Cancer (enzalutamide)
Participants with metastatic castration resistant prostate cancer (mCRPC) will receive enzalutamide at the discretion of his treating physician.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participant with histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
* Participant with documented metastatic prostate cancer
* Participant with documented castration resistance with progression of prostate cancer on androgen deprivation therapy (ADT)
* Participant who will be initiated on either abiraterone acetate or enzalutamide for the treatment of metastatic castration-resistant prostate cancer (mCRPC) that is asymptomatic or mildly symptomatic (per physician's evaluation) after failure of ADT at the time of treatment initiation
* Participants who signed a participation agreement or Informed consent form (ICF) per local regulations
* The treatment decision (abiraterone acetate or enzalutamide) by the treating physician must have been taken before enrollment into the study
* Baseline patient-reported outcomes (PROs) must be captured before the first administration of abiraterone acetate or enzalutamide.
Exclusion Criteria
* Participant who is not capable of completing a patient survey
* Participant who has received or is currently receiving abiraterone acetate or enzalutamide
* Patient receiving an investigational treatment for prostate cancer of any kind before or at the time of initiation of abiraterone acetate or enzalutamide
* Participant who is currently included in other observational studies with abiraterone acetate sponsored by Janssen
18 Years
MALE
No
Sponsors
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Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutica N.V., Belgium Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutica N.V., Belgium
Locations
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Holstebro, , Denmark
Næstved, , Denmark
Odense, , Denmark
Besançon, , France
Beuvry, , France
Bordeaux, , France
Challes-les-Eaux, , France
Chalon-sur-Saône, , France
Dijon, , France
Lyon, , France
Marseille, , France
Paris, , France
Quimper, , France
Saint-Mandé, , France
Strasbourg, , France
Toulouse, , France
Berkshire, , United Kingdom
Birmingham, , United Kingdom
Bolton, , United Kingdom
Derby, , United Kingdom
Glasgow, , United Kingdom
Lancaster, , United Kingdom
Middlesbrough, , United Kingdom
Oldham, , United Kingdom
Sutton, , United Kingdom
Wolverhampton, , United Kingdom
Countries
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References
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Thiery-Vuillemin A, Poulsen MH, Lagneau E, Ploussard G, Birtle A, Dourthe LM, Beal-Ardisson D, Pintus E, Trepiakas R, Lefresne F, Lukac M, Van Sanden S, Pissart G, Reid A; AQUARiUS Investigators. 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. Eur Urol. 2020 Mar;77(3):380-387. doi: 10.1016/j.eururo.2019.09.019. Epub 2019 Oct 5.
Other Identifiers
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212082PCR4039
Identifier Type: OTHER
Identifier Source: secondary_id
CR108141
Identifier Type: -
Identifier Source: org_study_id
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