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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   May 7, 2025

Want to learn how to participate in this trial?

CR109320

OVERVIEW

  • Sexes Eligible for Study
    male
  • Age
    18+ years
  • Phase
  • Sites
    53 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 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


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 apalutami

More...

DETAILS

LOCATIONS

Locations in:
Austria, France, Germany, Greece, Spain, United Kingdom
Country (6) City or Province (53) Status
Austria Wels Klinikum Wels Grieskirchen
RECRUITING
Austria Wien Akh Wien
RECRUITING
France Avignon Institut Sainte Catherine
RECRUITING
France Bordeaux Institut Bergonie
RECRUITING
France Bordeaux Polyclinique Bordeaux Nord Acquitaine
RECRUITING
France Brest Clinique Pasteur- Lanroze
RECRUITING
France La Tronche Hopital Michallon CHU Grenoble Alpes
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 Paris Hopital Tenon
RECRUITING
France Pontoise Centre Hospitalier Rene Dubos Pontoise
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
Germany Dierdorf Urologie Dierdorf
RECRUITING
Germany Dresden St. Elisabeth Hospital Leipzig
RECRUITING
Germany Duisburg Urologicum Duisburg
RECRUITING
Germany Gladenbach Urologisches Zentrum Mittelhessen
RECRUITING
Germany Hamburg Praxis Dr. Serkan Filiz
COMPLETED
Germany Muenster Universitaetsklinikum Muenster
RECRUITING
Germany Regensburg Krankenhaus Barmherzige Brüder Regensburg
RECRUITING
Greece Athens Anticancer Oncology Hospital of Athens Agios Savvas
RECRUITING
Greece Athens General Oncology Hospital of Kifisias "Agioi Anargyroi
RECRUITING
Greece Athina Alexandra General Hospital of Athens
RECRUITING
Greece Thessaloniki Papageorgiou General Hospital Of Thessaloniki
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 Hosp. Univ. Lucus Augusti
RECRUITING
Spain Santiago de Compostela Hosp. Clinico Univ. de Santiago
RECRUITING
Spain Valencia Hosp. Univ. I Politecni La Fe
RECRUITING
United Kingdom Berkshire Frimley Health NHS Foundation Trust
RECRUITING
United Kingdom Devon Torbay Hospital-Devon
RECRUITING
United Kingdom Guildford Royal Surrey County Hospital NHS Trust
RECRUITING
United Kingdom Oldham Pennine Care Nhs Foundation Trust
RECRUITING
United Kingdom Scunthorpe Scunthorpe General Hospital
RECRUITING
United Kingdom Worthing University Hospitals Sussex NHS Foundation Trust Worthing Hospital
RECRUITING
France Strasbourg Clinique Sainte Anne
RECRUITING
United Kingdom London Royal Free London NHS Foundation Trust
RECRUITING
Germany Mainz Universitatsmedizin der Johannes Gutenberg Universitat Mainz
RECRUITING
Greece Athens Attikon University General Hospital of Attica
COMPLETED
Greece Heraklion University Hospital of Heraklion
COMPLETED
Greece Patras University General Hospital of Rio Patras
RECRUITING
Spain A Coruna Hosp Univ A Coruna
RECRUITING
Spain Malaga Hosp Regional Univ de Malaga
RECRUITING
United Kingdom Cornwall Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
RECRUITING
United Kingdom Dorchester Dorset County Hospital Nhs Foundation Trust
RECRUITING
United Kingdom London University College London Hospitals Nhs Foundation Trust
RECRUITING
United Kingdom Taunton Taunton and Somerset NHS Foundation Trust
RECRUITING
Show More
Geo Locations

48.16667, 14.03333

48.20849, 16.37208

43.94834, 4.80892

44.84044, -0.5805

44.84044, -0.5805

48.3903, -4.48628

45.20429, 5.73645

45.74848, 4.84669

48.68439, 6.18496

43.83333, 4.35

48.85341, 2.3488

48.85341, 2.3488

49.05, 2.1

43.5852, 1.5272

48.15085, -1.68706

48.87143, 2.22929

43.60426, 1.44367

50.54647, 7.65271

51.05089, 13.73832

51.43247, 6.76516

50.76847, 8.58085

53.57532, 10.01534

51.96236, 7.62571

49.01513, 12.10161

37.97945, 23.71622

37.97945, 23.71622

37.9804964, 23.7561153

40.64361, 22.93086

36.83814, -2.45974

40.0120227, -0.0279867

36.52672, -6.2891

28.4853, -16.32014

43.00992, -7.55602

42.88052, -8.54569

39.46975, -0.37739

51.532009, -0.5739735

50.4823025, -3.5538193

51.23536, -0.57427

53.54051, -2.1183

53.57905, -0.65437

50.81795, -0.37538

48.58392, 7.74553

51.50853, -0.12574

49.98419, 8.2791

37.97945, 23.71622

35.32787, 25.14341

38.24444, 21.73444

43.37135, -8.396

36.72016, -4.42034

50.2666752, -5.0915109

50.71667, -2.43333

51.50853, -0.12574

51.01494, -3.10293

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10

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5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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