A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide (ArtemisPRO)
Last Updated   March 27, 2024 - 21:06
OVERVIEW
-
Gender
male -
Age
years -
Phase
phase -
Sites
sites -
Status
Recruiting
SUMMARY
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
- Metastatic hormone-sensitive prostate cancer
ELIGIBILITY
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 before 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 more than 2 months prior to apalutamide or enzalutamide treatment initiation
* Has received prior immediate docetaxel for the treatment of mHSPC
* Participants is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide
DETAILS
LOCATIONS
Country (6) | City or Province (37) | Status |
United Kingdom | Berkshire, BRK Frimley Health NHS Foundation Trust |
RECRUITING
|
United Kingdom | Devon Torbay Hospital-Devon |
RECRUITING
|
United Kingdom | Guildford, SRY Royal Surrey County Hospital NHS Trust |
RECRUITING
|
United Kingdom | Oldham Pennine Care Nhs Foundation Trust |
RECRUITING
|
United Kingdom | Scunthorpe Scunthorpe General Hospital |
RECRUITING
|
Spain | A Coruña Hosp. Univ. A Coruna |
RECRUITING
|
Spain | Almería Hosp. Torrecardenas |
RECRUITING
|
Spain | Castellon Hosp. Gral. Univ. de Castellon |
RECRUITING
|
Spain | Cádiz Hosp. Puerta Del Mar |
RECRUITING
|
Spain | La Laguna Hosp. Univ. de Canarias |
RECRUITING
|
Spain | Lugo, LG Hosp. Univ. Lucus Augusti |
RECRUITING
|
Spain | Malaga Hosp. Regional Univ. de Malaga |
RECRUITING
|
Spain | Santiago de Compostela Hosp. Clinico Univ. de Santiago |
RECRUITING
|
Spain | Valencia, VC Hosp. Univ. I Politecni La Fe |
RECRUITING
|
Greece | Athens Anticancer Oncology Hospital of Athens Agios Savvas |
RECRUITING
|
Greece | Heraklion University Hospital of Heraklion |
RECRUITING
|
Greece | Thessaloniki 'Papageorgiou' General Hospital of Thessaloniki |
RECRUITING
|
Germany | Dresden, SN St. Elisabeth Hospital Leipzig |
RECRUITING
|
Germany | Duisburg Urologicum Duisburg |
RECRUITING
|
Germany | Gladenbach, HE Urologisches Zentrum Mittelhessen |
RECRUITING
|
Germany | Hamburg, SH Praxis Dr. Serkan Filiz |
COMPLETED
|
Germany | Mainz, RP Universitätsmedizin der Johannes Gutenberg-Universität Mainz |
RECRUITING
|
Germany | Muenster Universitaetsklinikum Muenster |
RECRUITING
|
France | Avignon Institut Sainte Catherine |
RECRUITING
|
France | Bordeaux Institut Bergonié |
RECRUITING
|
France | Bordeaux Polyclinique Bordeaux Nord Acquitaine |
RECRUITING
|
France | Brest Clinique Pasteur- Lanroze |
RECRUITING
|
France | Lyon Hôpital Edouard Herriot |
RECRUITING
|
France | Nancy Centre d'oncologie de Gentilly |
RECRUITING
|
France | Nimes CHU Nîmes |
RECRUITING
|
France | Paris Hopital Europeen Georges-Pompidou |
RECRUITING
|
France | Quint-Fonsegrives Clinique de la Croix du Sud |
RECRUITING
|
France | Saint-Grégoire Centre Hospitalier Prive |
RECRUITING
|
France | Suresnes Hopital Foch |
RECRUITING
|
France | Toulouse cedex 9 CHU de Toulouse |
RECRUITING
|
Austria | Wels Klinikum Wels-Grieskirchen |
RECRUITING
|
Austria | Wien Akh Wien |
RECRUITING
|
Indicates 50+ sites in this region: click to zoom in.
Indicates 10+ sites in this region: click to zoom in.
Indicates < 10 sites in this region: click to zoom in.
Corresponds to individual site.