Informations générales (source: ClinicalTrials.gov)
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) (ArtemisPRO)
Observational
Janssen-Cilag Ltd. (Voir sur ClinicalTrials)
juillet 2023
juin 2026
04 avril 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | SLEIMAN Walid | 14/02/2025 09:03:13 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| HOPITAL FOCH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre d'oncologie de Gentilly - 54100 - Nancy - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Prive - 35760 - Saint-Grégoire - France | Contact (sur clinicalTrials) | ||||
| CHU de Toulouse - 31059 - Toulouse cedex 9 - France | Contact (sur clinicalTrials) | ||||
| CHU Nîmes - 30029 - Nimes - France | Contact (sur clinicalTrials) | ||||
| Clinique de la Croix du Sud - 31130 - Quint-Fonsegrives - France | Contact (sur clinicalTrials) | ||||
| Clinique Pasteur- Lanroze - 29229 - Brest - France | Contact (sur clinicalTrials) | ||||
| Clinique Sainte Anne - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hôpital Edouard Herriot - 69003 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hopital Michallon CHU Grenoble Alpes - 38700 - La Tronche - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - 84918 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Polyclinique Bordeaux Nord Acquitaine - 33077 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
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
- 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
- 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