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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)

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ClinicalTrials.gov Identifier: NCT02813408
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

May 24, 2016
June 27, 2016
June 4, 2018
May 3, 2016
March 21, 2018   (Final data collection date for primary outcome measure)
  • 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) ]
Same as current
Complete list of historical versions of study NCT02813408 on ClinicalTrials.gov Archive Site
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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
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).
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Participants who will initiate treatment with abiraterone acetate or enzalutamide at study entry will be observed.
Prostatic Neoplasms
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
206
March 21, 2018
March 21, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   United Kingdom
 
 
NCT02813408
CR108141
212082PCR4039 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium )
No
Studies a U.S. FDA-regulated Device Product: No
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Janssen Pharmaceutica N.V., Belgium
Janssen Pharmaceutica N.V., Belgium
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Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial Janssen Pharmaceutica N.V., Belgium
Janssen Pharmaceutica N.V., Belgium
May 2018