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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02813408
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 4, 2018
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

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).

Condition or disease
Prostatic Neoplasms

Study Type : Observational
Estimated Enrollment : 211 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 3, 2016
Actual Primary Completion Date : March 21, 2018
Actual Study Completion Date : March 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.

Primary Outcome Measures :
  1. Health Related Quality of Life (HRQoL) [ Time Frame: 12 months ]
  2. 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.

  3. 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.

  4. 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).

  5. Medical Resource Use (MRU) [ Time Frame: 6 months prior to baseline until the end of the follow-up period (up to 18 months) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who will initiate treatment with abiraterone acetate or enzalutamide at study entry will be observed.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02813408

Regionshospitalet i Holstebro
Holstebro N/A, Denmark, 7500
Næstved Hospital
Naestved, Denmark, 4700
Odense Universitetshospital
Odense, Denmark, 5000
Hopital Jean MINJOZ
Besancon Cedex, France, 25030
Centre de Radiotherapie de Beuvry
Beuvry, France, 62660
Chu Bordeaux.
Bordeaux, France, 33000
Medipole De Savoie
Challes-Les-Eaux, France, 73190
Cabinet d'Oncologie Médicale
Chalon Sur Saône, France, 71100
Centre d'oncologie et de radiothérapie du Parc
Dijon, France, 21000
Hopital Prive Jean Mermoz
Lyon, France, 69008
Clinique de la Sauvegarde
Lyon, France, 69009
APHM Hopital Timone
Marseille, France, 13005
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, France, 75012
Centre Hopitalier Inter-Communal De Cornouaille
Quimper, France, 29107
HIA Begin
Saint Mande, France, 94163
Polyclinique Ste Anne
Strasbourg, France, 67000
Clinique Saint Jean Languedoc
Toulouse, France, 31400
United Kingdom
Frimley Health NHS Foundation Trust
Berkshire, United Kingdom, SL2 4HL
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Royal Bolton NHS Foundation Trust
Bolton, United Kingdom, BL4 OJR
Derby City Hospital
Derby, United Kingdom, DE22 3DT
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Royal Lancaster Infirmary
Lancaster, United Kingdom, LA1 4RP
James Cook University Hospital
Middlesbrough, United Kingdom, TS3 4BW
The Royal Oldham Hospital
Oldham, United Kingdom, OL1 2JH
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
New Cross Hospital
Wolverhampton., United Kingdom, WV10 0QP
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial Janssen Pharmaceutica N.V., Belgium

Responsible Party: Janssen Pharmaceutica N.V., Belgium Identifier: NCT02813408     History of Changes
Other Study ID Numbers: CR108141
212082PCR4039 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium )
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors