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)

May 23, 2019 updated by: Janssen Pharmaceutica N.V., Belgium

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holstebro N/a, Denmark
      • Naestved, Denmark
      • Odense, Denmark
  • France
      • Besancon Cedex, France
      • Beuvry, France
      • Bordeaux, France
      • Challes-les-Eaux, France
      • Chalon sur Saône, France
      • Dijon, France
      • Lyon, France
      • Marseille, France
      • Paris, France
      • Quimper, France
      • Saint Mande, France
      • Strasbourg, France
      • Toulouse, France
  • United Kingdom
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Participants who will initiate treatment with abiraterone acetate or enzalutamide at study entry will be observed.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Participants with Prostate Cancer (enzalutamide)
Participants with metastatic castration resistant prostate cancer (mCRPC) will receive enzalutamide at the discretion of his treating physician.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life (HRQoL)
Time Frame: 12 months
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.
12 months
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.
12 months
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).
12 months
Medical Resource Use (MRU)
Time Frame: 6 months prior to baseline until the end of the follow-up period (up to 18 months)
6 months prior to baseline until the end of the follow-up period (up to 18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Pharmaceutica N.V., Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108141
  • 212082PCR4039 (Other Identifier: Janssen Pharmaceutica N.V., Belgium)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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