Clinical trial · Observational
A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
Prospective, Multi-Country, Observational Study of Clinical Outcomes for Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With ADT Plus Apalutamide or Enzalutamide Under Routine Clinical Practice (ArtemisPRO)
NCT05901649CI-TRIAL-00120204ArtemisPROcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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 study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mHSPC).
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 |
|---|---|---|---|
| Metastatic Hormone-sensitive Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apalutamide | Drug | Apalutamide | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Apalutamide Plus Androgen Deprivation Therapy (ADT)
- description
- Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with apalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.
- interventionNames
- Drug: Apalutamide
- label
- Enzalutamide Plus Androgen Deprivation Therapy (ADT)
- description
- Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with enzalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.
- interventionNames
- Drug: Enzalutamide
Primary outcomes (5)
- measure
- Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have a histologically or cytologically-confirmed diagnosis of adenocarcinoma of the prostate * Must have documented metastatic hormone-sensitive prostate cancer (mHSPC) * Must have agreed with the treating physician the initiation of either apalutamide or enzalutamide (plus androgen deprivation therapy \[ADT\]) treatment, per the treating physician's decision, prior to enrollment into the study * Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/ informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements * Must have baseline prostate-specific antigen (PSA) captured within 30 days prior to the first administration of apalutamide or enzalutamide * Must agree to complete patient-reported outcomes (PROs) during the study, including the baseline ones collected before the first administration of apalutamide or enzalutamide Exclusion Criteria: * Has already received or is currently receiving either apalutamide or enzalutamide, or any other novel hormonal treatments (including but not limited to abiraterone acetate and darolutamide) * Is currently receiving an active treatment for prostate cancer as part of an interventional study * Has a progression under ADT treatment (and thus became castrate-resistant) prior to start of apalutamide or enzalutamide treatment * Has received ADT treatment for mHSPC for more than 2 months prior to apalutamide or enzalutamide treatment initiation or ADT treatment was administered for earlier disease stages within the last 12 months prior to apalutamide or enzalutamide treatment initiation * Has received prior docetaxel for the treatment of mHSPC * Participants is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide
References
Publications (0)
Data not yet available
No reference posted for this study.