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Comparing outcomes of two treatments for metastatic hormone-sensitive prostate cancer

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)

Observational Janssen-Cilag Ltd. · NCT05901649

This study looks at how well two different treatments, apalutamide and enzalutamide, work for men with metastatic hormone-sensitive prostate cancer when used with hormone therapy.

Quick facts

Study typeObservational
Enrollment450 (estimated)
Ages18 Years and up
SexMale
SponsorJanssen-Cilag Ltd. Industry-sponsored
Locations53 sites (Wels and 52 other locations)
Trial IDNCT05901649 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the real-world outcomes of patients with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with either apalutamide or enzalutamide in combination with androgen deprivation therapy (ADT). Participants will be monitored for their treatment responses and side effects, with data collected on their prostate-specific antigen (PSA) levels and patient-reported outcomes. The study is observational, meaning it will analyze existing treatment patterns rather than randomizing participants to different therapies.

Who should consider this trial

Good fit: Ideal candidates include men with a confirmed diagnosis of adenocarcinoma of the prostate who have documented metastatic hormone-sensitive prostate cancer and are starting treatment with either apalutamide or enzalutamide.

Not a fit: Patients who do not have metastatic hormone-sensitive prostate cancer or those who are not starting treatment with apalutamide or enzalutamide may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into which treatment option may offer better outcomes for patients with mHSPC.

How similar studies have performed: Other studies have shown promising results with similar treatment approaches in metastatic hormone-sensitive prostate cancer, indicating that this area of research is both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Wels and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Hormone-sensitive Prostate Cancer
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.