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 (AQUARiUS)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Prostatic Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT02813408

CR108141

212082PCR4039 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 226 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

226 participants in 2 patient groups

Participants with Prostate Cancer (abiraterone acetate)

Description:

Participants with metastatic castration resistant prostate cancer (mCRPC) will receive abiraterone acetate at the discretion of his treating physician.

Participants with Prostate Cancer (enzalutamide)

Description:

Participants with metastatic castration resistant prostate cancer (mCRPC) will receive enzalutamide at the discretion of his treating physician.