ArtemisPRO
Research type
Research Study
Full title
Prospective, Multi‐Country, Observational Study of Clinical Outcomes for Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With ADT plus Apalutamide or Enzalutamide Under Routine Clinical Practice (ArtemisPRO)
IRAS ID
324526
Contact name
Elias Pintus
Contact email
Sponsor organisation
Janssen Cilag NV
Clinicaltrials.gov Identifier
54997, CPMS-NIHR
Duration of Study in the UK
2 years, 5 months, 17 days
Research summary
ERLEADA® (apalutamide) and Xtandi® (enzalutamide) are both indicated for the treatment of patients with mHSPC. In Phase 3 placebo-controlled studies, addition of apalutamide or enzalutamide to ADT improved overall survival, and reduced risk of disease progression.
Recent data showed emerging differences between apalutamide and enzalutamide in outcomes such as quality of life. It has been shown for apalutamide, that the impact of a steep and deep PSA-decline has a correlation with an improved overall survival and that there is a correlation with better health-related quality of life for mHSPC patients.
Thus, there is need for undertaking an observational prospective study to better characterize the PSA kinetics and the important health-related quality of life elements in mHSPC patients, in order to enable better treatment and supportive care planning in this patient group.
This is a prospective, multicenter non-interventional study to describe the treatment of mHSPC with either apalutamide plus ADT or enzalutamide plus ADT in a clinical practice setting, and document its impact on PSA kinetics, HRQoL, fatigue, cognitive function and PSA anxiety. Patients observed in this study will be adults aged 18 years and older with a diagnosis of mHSPC treated in a clinical practice setting, who will be invited to participate in the study by their treating physician at the time of initiation of mHSPC treatment with either apalutamide or enzalutamide. The decision to treat patients with apalutamide or enzalutamide must have been taken independently of and before enrolling the patient into the study; additionally,
treatment decisions and clinical management of patients will be at the discretion of the treating physician, per routine clinical practice.REC name
London - Queen Square Research Ethics Committee
REC reference
23/PR/0509
Date of REC Opinion
23 Jun 2023
REC opinion
Further Information Favourable Opinion