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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.
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

Full criteria on ClinicalTrials.gov

Sites (53)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Akh Wien
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ViennaAustriaUnknown status
Klinikum Wels-Grieskirchen
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WelsAustriaUnknown status
Urologie Dierdorf
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DierdorfGermanyUnknown status
St. Elisabeth Hospital Leipzig
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DresdenGermanyUnknown status
Urologicum Duisburg
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DuisburgGermanyUnknown status
Urologisches Zentrum Mittelhessen
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GladenbachGermanyUnknown status
Praxis Dr. Serkan Filiz
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HamburgGermanyUnknown status
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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MainzGermanyUnknown status
Universitaetsklinikum Muenster
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MünsterGermanyUnknown status
Krankenhaus Barmherzige Brüder Regensburg
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RegensburgGermanyUnknown status
Hosp Univ A Coruna
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A CoruñaSpainUnknown status
Hosp. Torrecardenas
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AlmeríaSpainUnknown status
Hosp. Puerta Del Mar
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CadizSpainUnknown status
Hosp. Gral. Univ. de Castellon
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CastellonSpainUnknown status
Hosp. Univ. Lucus Augusti
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LugoSpainUnknown status
Hosp Regional Univ de Malaga
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MálagaSpainUnknown status
Hosp. Univ. de Canarias
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San Cristóbal de La LagunaSpainUnknown status
Hosp. Clinico Univ. de Santiago
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Santiago de CompostelaSpainUnknown status
Hosp. Univ. I Politecni La Fe
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ValenciaSpainUnknown status
Institut Sainte-Catherine
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AvignonFranceUnknown status
Polyclinique Bordeaux Nord Acquitaine
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BordeauxFranceUnknown status
Institut Bergonie
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BordeauxFranceUnknown status
Clinique Pasteur Lanroze
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BrestFranceUnknown status
Hopital Michallon CHU Grenoble Alpes
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La TroncheFranceUnknown status
Hopital Edouard Herriot
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LyonFranceUnknown status
Centre d Oncologie de Gentilly
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NancyFranceUnknown status
CHU Nîmes
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NîmesFranceUnknown status
Hôpital Européen Georges Pompidou
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ParisFranceUnknown status
Hôpital Tenon
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ParisFranceUnknown status
Centre Hospitalier Rene Dubos Pontoise
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PontoiseFranceUnknown status
Clinique de la Croix du Sud
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Quint-FonsegrivesFranceUnknown status
Centre Hospitalier Prive
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Saint-GrégoireFranceUnknown status
Clinique Sainte Anne
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StrasbourgFranceUnknown status
Hopital Foch
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SuresnesFranceUnknown status
CHU de Toulouse
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ToulouseFranceUnknown status
Lewisham & Greenwich NHS Trust
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BerkshireUnited KingdomUnknown status
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
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CornwallUnited KingdomUnknown status
Torbay Hospital-Devon
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DevonUnited KingdomUnknown status
Dorset County Hospital NHS Foundation Trust
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DorchesterUnited KingdomUnknown status
Royal Surrey County Hospital NHS Trust
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GuildfordUnited KingdomUnknown status
University College London Hospitals NHS Foundation Trust
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LondonUnited KingdomUnknown status
Royal Free London NHS Foundation Trust
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LondonUnited KingdomUnknown status
Northern Care Alliance NHS Foundation Trust
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OldhamUnited KingdomUnknown status
Northern Lincolnshire and Goole NHS Foundation Trust
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ScunthorpeUnited KingdomUnknown status
Taunton and Somerset NHS Foundation Trust
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TauntonUnited KingdomUnknown status
University Hospitals Sussex NHS Foundation Trust Worthing Hospital
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WorthingUnited KingdomUnknown status
Attikon University General Hospital of Attica
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AthensGreeceUnknown status
Alexandra General Hospital of Athens
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AthensGreeceUnknown status
Anticancer Oncology Hospital of Athens Agios Savvas
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AthensGreeceUnknown status
General Oncology Hospital of Kifisias "Agioi Anargyroi
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AthensGreeceUnknown status
University Hospital of Heraklion
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HeraklionGreeceUnknown status
University General Hospital of Rio Patras
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PátraiGreeceUnknown status
Papageorgiou General Hospital of Thessaloniki
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ThessalonikiGreeceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.