A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
NCT ID: NCT05901649
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
503 participants
OBSERVATIONAL
2023-07-05
2026-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Enzalutamide Plus Androgen Deprivation Therapy (ADT)
Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with enzalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.
Enzalutamide
No interventions will be administered as a part of this study. Participants will receive enzalutamide as per their routine clinical practice.
Apalutamide Plus Androgen Deprivation Therapy (ADT)
Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with apalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.
Apalutamide
No interventions will be administered as a part of this study. Participants will receive apalutamide as per their routine clinical practice.
Interventions
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Apalutamide
No interventions will be administered as a part of this study. Participants will receive apalutamide as per their routine clinical practice.
Enzalutamide
No interventions will be administered as a part of this study. Participants will receive enzalutamide as per their routine clinical practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Janssen-Cilag Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag Ltd Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag Ltd.
Locations
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Akh Wien
Vienna, , Austria
Klinikum Wels Grieskirchen
Wels, , Austria
Institut Sainte Catherine
Avignon, , France
Institut Bergonie
Bordeaux, , France
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, , France
Clinique Pasteur- Lanroze
Brest, , France
Hopital Michallon CHU Grenoble Alpes
La Tronche, , France
Hôpital Edouard Herriot
Lyon, , France
Centre d'oncologie de Gentilly
Nancy, , France
CHU Nimes
Nîmes, , France
Hopital Europeen Georges-Pompidou
Paris, , France
Hopital Tenon
Paris, , France
Centre Hospitalier Rene Dubos Pontoise
Pontoise, , France
Clinique de la Croix du Sud
Quint-Fonsegrives, , France
Centre Hospitalier Prive
Saint-Grégoire, , France
Clinique Sainte Anne
Strasbourg, , France
Hopital Foch
Suresnes, , France
CHU de Toulouse
Toulouse, , France
Urologie Dierdorf
Dierdorf, , Germany
St. Elisabeth Hospital Leipzig
Dresden, , Germany
Urologicum Duisburg
Duisburg, , Germany
Urologisches Zentrum Mittelhessen
Gladenbach, , Germany
Praxis Dr. Serkan Filiz
Hamburg, , Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, , Germany
Alexandra General Hospital of Athens
Athens, , Greece
Anticancer Oncology Hospital of Athens Agios Savvas
Athens, , Greece
Attikon University General Hospital of Attica
Athens, , Greece
General Oncology Hospital of Kifisias "Agioi Anargyroi
Athens, , Greece
University Hospital of Heraklion
Heraklion, , Greece
University General Hospital of Rio Patras
Pátrai, , Greece
Papageorgiou General Hospital Of Thessaloniki
Thessaloniki, , Greece
Hosp Univ A Coruna
A Coruña, , Spain
Hosp. Torrecardenas
Almería, , Spain
Hosp. Puerta Del Mar
Cadiz, , Spain
Hosp. Gral. Univ. de Castellon
Castellon, , Spain
Hosp. Univ. Lucus Augusti
Lugo, , Spain
Hosp Regional Univ de Malaga
Málaga, , Spain
Hosp. Univ. de Canarias
San Cristóbal de La Laguna, , Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Frimley Health NHS Foundation Trust
Berkshire, , United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Cornwall, , United Kingdom
Torbay Hospital-Devon
Devon, , United Kingdom
Dorset County Hospital Nhs Foundation Trust
Dorchester, , United Kingdom
Royal Surrey County Hospital NHS Trust
Guildford, , United Kingdom
University College London Hospitals Nhs Foundation Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Pennine Care Nhs Foundation Trust
Oldham, , United Kingdom
Scunthorpe General Hospital
Scunthorpe, , United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, , United Kingdom
University Hospitals Sussex NHS Foundation Trust Worthing Hospital
Worthing, , United Kingdom
Countries
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Other Identifiers
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56021927PCR4031
Identifier Type: OTHER
Identifier Source: secondary_id
CR109320
Identifier Type: -
Identifier Source: org_study_id