NCT05901649Completed
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)
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 505 (actual)
- First submitted
- 5 Jun 2023
- Start date
- 5 Jul 2023
- Primary completion date
- 16 Jun 2026
- Lead sponsor
- Janssen-Cilag Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT05901649
What you commit to
- Study type: Observational
- Participants enrolled: 505
- From 5 Jul 2023 to the primary completion date, 16 Jun 2026
- 53 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Participants is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (53)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akh Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Klinikum Wels-Grieskirchen Coordinator of this site? Confirm its status | Wels | Austria | Unknown status |
| Urologie Dierdorf Coordinator of this site? Confirm its status | Dierdorf | Germany | Unknown status |
| St. Elisabeth Hospital Leipzig Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Urologicum Duisburg Coordinator of this site? Confirm its status | Duisburg | Germany | Unknown status |
| Urologisches Zentrum Mittelhessen Coordinator of this site? Confirm its status | Gladenbach | Germany | Unknown status |
| Praxis Dr. Serkan Filiz Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Universitaetsklinikum Muenster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Krankenhaus Barmherzige Brüder Regensburg Coordinator of this site? Confirm its status | Regensburg | Germany | Unknown status |
| Hosp Univ A Coruna Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hosp. Torrecardenas Coordinator of this site? Confirm its status | Almería | Spain | Unknown status |
| Hosp. Puerta Del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| Hosp. Gral. Univ. de Castellon Coordinator of this site? Confirm its status | Castellon | Spain | Unknown status |
| Hosp. Univ. Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hosp Regional Univ de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hosp. Univ. de Canarias Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Unknown status |
| Hosp. Clinico Univ. de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hosp. Univ. I Politecni La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Institut Sainte-Catherine Coordinator of this site? Confirm its status | Avignon | France | Unknown status |
| Polyclinique Bordeaux Nord Acquitaine Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Clinique Pasteur Lanroze Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Hopital Michallon CHU Grenoble Alpes Coordinator of this site? Confirm its status | La Tronche | France | Unknown status |
| Hopital Edouard Herriot Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Centre d Oncologie de Gentilly Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| CHU Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Tenon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Rene Dubos Pontoise Coordinator of this site? Confirm its status | Pontoise | France | Unknown status |
| Clinique de la Croix du Sud Coordinator of this site? Confirm its status | Quint-Fonsegrives | France | Unknown status |
| Centre Hospitalier Prive Coordinator of this site? Confirm its status | Saint-Grégoire | France | Unknown status |
| Clinique Sainte Anne Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Unknown status |
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Lewisham & Greenwich NHS Trust Coordinator of this site? Confirm its status | Berkshire | United Kingdom | Unknown status |
| Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital Coordinator of this site? Confirm its status | Cornwall | United Kingdom | Unknown status |
| Torbay Hospital-Devon Coordinator of this site? Confirm its status | Devon | United Kingdom | Unknown status |
| Dorset County Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Dorchester | United Kingdom | Unknown status |
| Royal Surrey County Hospital NHS Trust Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Free London NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Northern Care Alliance NHS Foundation Trust Coordinator of this site? Confirm its status | Oldham | United Kingdom | Unknown status |
| Northern Lincolnshire and Goole NHS Foundation Trust Coordinator of this site? Confirm its status | Scunthorpe | United Kingdom | Unknown status |
| Taunton and Somerset NHS Foundation Trust Coordinator of this site? Confirm its status | Taunton | United Kingdom | Unknown status |
| University Hospitals Sussex NHS Foundation Trust Worthing Hospital Coordinator of this site? Confirm its status | Worthing | United Kingdom | Unknown status |
| Attikon University General Hospital of Attica Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Alexandra General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Anticancer Oncology Hospital of Athens Agios Savvas Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| General Oncology Hospital of Kifisias "Agioi Anargyroi Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| University Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Unknown status |
| University General Hospital of Rio Patras Coordinator of this site? Confirm its status | Pátrai | Greece | Unknown status |
| Papageorgiou General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.