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

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OVERVIEW

  • Gender
    male
  • Age
    18+ years
  • Phase
    - phase
  • Sites
    37 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

Locations in:
United Kingdom, Spain, Greece, Germany, France, Austria
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
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50

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10

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5

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Corresponds to individual site.

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