- ICH GCP
- US Clinical Trials Registry
- 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 (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
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
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
-
-
-
Holstebro N/a, Denmark
-
Naestved, Denmark
-
Odense, Denmark
-
-
-
-
-
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
-
-
-
-
-
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
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 |
---|
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
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.
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.
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)
May 3, 2016
Primary Completion (Actual)
March 21, 2018
Study Completion (Actual)
March 21, 2018
Study Registration Dates
First Submitted
May 24, 2016
First Submitted That Met QC Criteria
June 22, 2016
First Posted (Estimate)
June 27, 2016
Study Record Updates
Last Update Posted (Actual)
May 24, 2019
Last Update Submitted That Met QC Criteria
May 23, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostatic Neoplasms
-
Technische Universität DresdenRecruitingOligometastatic Disease | Prostatic Cancer, Castration-ResistantGermany
-
Australian and New Zealand Urogenital and Prostate...Peter MacCallum Cancer Centre, AustraliaRecruitingCastration Resistant Prostatic CancerAustralia
-
British Columbia Cancer AgencySanofi; Ozmosis Research Inc.UnknownMetastatic Castration-Resistant Prostatic CancerCanada, Australia
-
Janssen Research & Development, LLCCompletedCastration-Resistant Prostatic NeoplasmsCanada, Belgium, United States, Spain, Netherlands, Italy, Russian Federation
-
Universität des SaarlandesRecruitingProstate Cancer Metastatic | Advanced Prostate Carcinoma | Castration Resistant Prostatic CancerGermany
-
Yinghao SunNot yet recruitingCastration-Resistant Prostatic Cancer
-
Institut Claudius RegaudWithdrawnProstatic Cancer, Castration-ResistantFrance
-
University Hospital, GrenobleTerminatedCastration-resistant Prostate CancerFrance
-
Michael Graham PhD, MDUniversity of Iowa; Holden Comprehensive Cancer CenterActive, not recruitingProstate Cancer | Prostatic Neoplasms, Castration-Resistant | Prostatic Neoplasm | Prostatic Cancer Recurrent | Prostatic Cancer MetastaticUnited States
-
Rio de Janeiro State UniversityCompletedProstatic Cancer | Prostatic NeoplasmBrazil