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Prostatic NeoplasmsAQUARiUSNCT02813408

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

An observational study of Prostatic Neoplasms, run by Janssen Pharmaceutica N.V., Belgium at 26 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
How many people
226 participants
Where
26 sitesin 3 countries
Study dates
3 May 2016to 21 Mar 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

26 sites in 3 countries.

26 sites in 3 countries

France13 sites

  • Study site

    Besançon

  • Study site

    Beuvry

  • Study site

    Bordeaux

  • Study site

    Challes-les-Eaux

  • Study site

    Chalon-sur-Saône

  • Study site

    Dijon

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Paris

  • Study site

    Quimper

  • Study site

    Saint-Mandé

  • Study site

    Strasbourg

  • Study site

    Toulouse

Other trials in France

United Kingdom10 sites

  • Study site

    Berkshire

  • Study site

    Birmingham

  • Study site

    Bolton

  • Study site

    Derby

  • Study site

    Glasgow

  • Study site

    Lancaster

  • Study site

    Middlesbrough

  • Study site

    Oldham

  • Study site

    Sutton

  • Study site

    Wolverhampton

Other trials in United Kingdom

Denmark3 sites

  • Study site

    Holstebro

  • Study site

    Næstved

  • Study site

    Odense

Other trials in Denmark

About this study

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

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).

Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02813408
Study groupRoleWhat they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Health Related Quality of Life (HRQoL)

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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).

    Measured: 12 months

  5. Medical Resource Use (MRU)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2016 (estimated)
  2. Study start3 May 2016
  3. Primary completion21 Mar 2018
  4. Study completion21 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02813408
Sponsor's protocol ID
CR108141
Other IDs
212082PCR4039
Acronym
AQUARiUS
Status last verified
May 2019
First submitted
24 May 2016
Last updated
24 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31594705

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Neoplasms, run by Janssen Pharmaceutica N.V., Belgium at 26 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in France, United Kingdom, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Related Quality of Life (HRQoL) (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02813408, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.

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