NCT02813408

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
3 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2018

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

May 24, 2016

Last Update Submit

May 23, 2019

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (5)

  • Health Related Quality of Life (HRQoL)

    12 months

  • Fatigue (BFI-SF)

    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)

    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)

    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)

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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Holstebro, Denmark

Location

Unknown Facility

Næstved, Denmark

Location

Unknown Facility

Odense, Denmark

Location

Unknown Facility

Besançon, France

Location

Unknown Facility

Beuvry, France

Location

Unknown Facility

Bordeaux, France

Location

Unknown Facility

Challes-les-Eaux, France

Location

Unknown Facility

Chalon-sur-Saône, France

Location

Unknown Facility

Dijon, France

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Marseille, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Quimper, France

Location

Unknown Facility

Saint-Mandé, France

Location

Unknown Facility

Strasbourg, France

Location

Unknown Facility

Toulouse, France

Location

Unknown Facility

Berkshire, United Kingdom

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Bolton, United Kingdom

Location

Unknown Facility

Derby, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

Lancaster, United Kingdom

Location

Unknown Facility

Middlesbrough, United Kingdom

Location

Unknown Facility

Oldham, United Kingdom

Location

Unknown Facility

Sutton, United Kingdom

Location

Unknown Facility

Wolverhampton, United Kingdom

Location

Related Publications (1)

  • Thiery-Vuillemin A, Poulsen MH, Lagneau E, Ploussard G, Birtle A, Dourthe LM, Beal-Ardisson D, Pintus E, Trepiakas R, Lefresne F, Lukac M, Van Sanden S, Pissart G, Reid A; AQUARiUS Investigators. Impact of Abiraterone Acetate plus Prednisone or Enzalutamide on Patient-reported Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer: Final 12-mo Analysis from the Observational AQUARiUS Study. Eur Urol. 2020 Mar;77(3):380-387. doi: 10.1016/j.eururo.2019.09.019. Epub 2019 Oct 5.

    PMID: 31594705DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Janssen Pharmaceutica N.V., Belgium Clinical Trial

    Janssen Pharmaceutica N.V., Belgium

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 27, 2016

Study Start

May 3, 2016

Primary Completion

March 21, 2018

Study Completion

March 21, 2018

Last Updated

May 24, 2019

Record last verified: 2019-05

Locations

DK(3)FR(13)GB(10)