Clinical trial NCT05901649: A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Hormone-sensitive Prostate Cancer
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-13
Enrollment: 450
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with high-risk metastatic hormone-sensitive prostate cancer (mHSPC) who will be treated with either apalutamide or enzalutamide plus androgen deprivation therapy (ADT) under routine clinical practice will be observed.

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3
timeFrame: At month 3
measure: Health-Related Quality of Life (HRQoL) as Assessed by Partial European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Questionnaire
timeFrame: Up to 30 Months
measure: Cognitive Functioning as Assessed by Partial Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire
timeFrame: Up to 30 Months
measure: Fatigue as Assessed by Brief Fatigue Inventory-Short Form (BFI-SF) Questionnaire
timeFrame: Up to 30 Months
measure: Prostate-specific Antigen (PSA) Anxiety as Assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire
timeFrame: Up to 30 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Klinikum Wels Grieskirchen
city: Wien
country: Austria
facility: Akh Wien
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bordeaux
country: France
facility: Institut Bergonie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Acquitaine
city: Brest
country: France
facility: Clinique Pasteur- Lanroze
city: La Tronche
country: France
facility: Hopital Michallon CHU Grenoble Alpes
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Nancy
country: France
facility: Centre d'oncologie de Gentilly
city: Nimes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: Hopital Europeen Georges-Pompidou
city: Paris
country: France
facility: Hopital Tenon
city: Pontoise
country: France
facility: Centre Hospitalier Rene Dubos Pontoise
city: Quint-Fonsegrives
country: France
facility: Clinique de la Croix du Sud
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Prive
city: Strasbourg
country: France
facility: Clinique Sainte Anne
city: Suresnes
country: France
facility: Hopital Foch
city: Toulouse cedex 9
country: France
facility: CHU de Toulouse
city: Dierdorf
country: Germany
facility: Urologie Dierdorf
city: Dresden
country: Germany
facility: St. Elisabeth Hospital Leipzig
city: Duisburg
country: Germany
facility: Urologicum Duisburg
city: Gladenbach
country: Germany
facility: Urologisches Zentrum Mittelhessen
city: Hamburg
country: Germany
facility: Praxis Dr. Serkan Filiz
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg Universitat Mainz
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg
city: Athens
country: Greece
facility: Anticancer Oncology Hospital of Athens Agios Savvas
city: Athens
country: Greece
facility: Attikon University General Hospital of Attica
city: Athens
country: Greece
facility: General Oncology Hospital of Kifisias "Agioi Anargyroi
city: Athina
country: Greece
facility: Alexandra General Hospital of Athens
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Patras
country: Greece
facility: University General Hospital of Rio Patras
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital Of Thessaloniki
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Almería
country: Spain
facility: Hosp. Torrecardenas
city: Castellon
country: Spain
facility: Hosp. Gral. Univ. de Castellon
city: Cádiz
country: Spain
facility: Hosp. Puerta Del Mar
city: La Laguna
country: Spain
facility: Hosp. Univ. de Canarias
city: Lugo
country: Spain
facility: Hosp. Univ. Lucus Augusti
city: Malaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Berkshire
country: United Kingdom
facility: Frimley Health NHS Foundation Trust
city: Cornwall
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
city: Devon
country: United Kingdom
facility: Torbay Hospital-Devon
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital Nhs Foundation Trust
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Trust
city: London
country: United Kingdom
facility: University College London Hospitals Nhs Foundation Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: Oldham
country: United Kingdom
facility: Pennine Care Nhs Foundation Trust
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust
city: Worthing
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust Worthing Hospital
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd Clinical Trial
role: STUDY_DIRECTOR
References: