Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Participants with Prostate Cancer (abiraterone acetate)
- description
- Participants with metastatic castration resistant prostate cancer (mCRPC) will receive abiraterone acetate at the discretion of his treating physician.
- label
- Participants with Prostate Cancer (enzalutamide)
- description
- Participants with metastatic castration resistant prostate cancer (mCRPC) will receive enzalutamide at the discretion of his treating physician.
Primary outcomes (5)
- measure
- Health Related Quality of Life (HRQoL)
- timeFrame
- 12 months
- measure
- Fatigue (BFI-SF)
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDThiery-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 31594705