Clinical trial NCT02813408: 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
Official title: Prospective Multi-country Observational Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Patient-reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2016-06-27
Enrollment: 226
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who will initiate treatment with abiraterone acetate or enzalutamide at study entry will be observed.

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Male 18 years of age or older
* 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:

* Patient who has received any chemotherapy/cytotoxic agent to treat their mCRPC before abiraterone acetate or enzalutamide initiation; or ; treat their metastatic hormone-sensitive prostate cancer (mHSPC) \<12 months prior to abiraterone acetate or enzalutamide initiation.
* 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

Primary outcomes:
measure: Health Related Quality of Life (HRQoL)
timeFrame: 12 months
measure: Fatigue (BFI-SF)
timeFrame: 12 months
measure: Pain (BPI-SF)
timeFrame: 12 months
measure: Cognitive Function (FACT-Cog)
timeFrame: 12 months
measure: Medical Resource Use (MRU)
timeFrame: 6 months prior to baseline until the end of the follow-up period (up to 18 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro N/a
country: Denmark
city: Naestved
country: Denmark
city: Odense
country: Denmark
city: Besancon Cedex
country: France
city: Beuvry
country: France
city: Bordeaux
country: France
city: Challes-les-Eaux
country: France
city: Chalon sur Saône
country: France
city: Dijon
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Paris
country: France
city: Quimper
country: France
city: Saint Mande
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Berkshire
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Bolton
country: United Kingdom
city: Derby
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Lancaster
country: United Kingdom
city: Middlesbrough
country: United Kingdom
city: Oldham
country: United Kingdom
city: Sutton
country: United Kingdom
city: Wolverhampton.
country: United Kingdom
Study officials:
affiliation: Janssen Pharmaceutica N.V., Belgium
name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.