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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Holstebro, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Health Related Quality of Life (HRQoL)

Time frame: 12 months
Fatigue (BFI-SF)

Time frame: 12 months

Brief Fatigue Inventory-Short Form (BFI-SF) assess the severity of fatigue and the impact of fatigue on daily functioning. BFI-SF is a 4 item questionnaire. Each item is assessed on a 11point scale, ranges from 0 (No Fatigue) to 10 (As bad as you can imagine). Average from all 4 items will be used to derive the final score.
Pain (BPI-SF)

Time frame: 12 months

Brief Pain Inventory-Short Form (BPI-SF) measures severity of pain, impact of pain on daily function, locations of pain, pain medications, and amount of pain relief in the past 24 hours or the past week. The BPI-SF includes 4 items measuring the intensity of pain which make up the pain intensity sub scales, assessed using 11 point numerical rating scales from "0"= no pain to "10" = pain as bad as you can imagine; 7 items that assess how much pain has interfered with 7 daily activities which make up the pain interference sub scale, assessed on a scale of 0, "Does not interfere" to 10, "completely interferes." This sub scale is typically scored as the mean of the 7 interference items; An additional item on the extent of pain relief.
Cognitive Function (FACT-Cog)

Time frame: 12 months

The Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) is a validated, 37 item, subjective neuro-psychological instrument designed to evaluate cancer participants perceived cognitive deterioration on their quality of life. The FACT-Cog is composed of 37 single items ranging from 04. Based on these single items 4 sub scales are calculated as perceived Cognitive Impairments (20 items; score range 0-80), impact On QOL (4 items; score range 0-16), comments From Others (4 items; score range 0-16), perceived Cognitive Abilities (9 items; score range 0-36).
Medical Resource Use (MRU)

Time frame: 6 months prior to baseline until the end of the follow-up period (up to 18 months)

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutica N.V., Belgium

Industry

Registry information

Official study 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

Acronym: AQUARiUS

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jun 27, 2016
Registry last updated: May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed