A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide

Metastatic Hormone-sensitive Prostate Cancer Clinical Trial

— ArtemisPRO  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05901649
• Other study ID #: CR109320
• Secondary ID: 56021927PCR4031
• Status: Recruiting
• Start date: July 5, 2023
• Est. completion date: September 5, 2025

Study information

• Verified date: May 2024
• Source: Janssen-Cilag Ltd.
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 5, 2025
• Est. primary completion date: September 5, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hypersensitivity
• Metastatic Hormone-sensitive Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Austria	Klinikum Wels-Grieskirchen	Wels
Austria	Akh Wien	Wien
France	Institut Sainte Catherine	Avignon
France	Institut Bergonié	Bordeaux
France	Polyclinique Bordeaux Nord Acquitaine	Bordeaux
France	Clinique Pasteur- Lanroze	Brest
France	Hôpital Edouard Herriot	Lyon
France	Centre d'oncologie de Gentilly	Nancy
France	CHU Nîmes	Nimes
France	Hopital Europeen Georges-Pompidou	Paris
France	Clinique de la Croix du Sud	Quint-Fonsegrives
France	Centre Hospitalier Prive	Saint-Grégoire
France	Hopital Foch	Suresnes
France	CHU de Toulouse	Toulouse cedex 9
Germany	St. Elisabeth Hospital Leipzig	Dresden
Germany	Urologicum Duisburg	Duisburg
Germany	Urologisches Zentrum Mittelhessen	Gladenbach
Germany	Praxis Dr. Serkan Filiz	Hamburg
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Universitaetsklinikum Muenster	Muenster
Greece	Anticancer Oncology Hospital of Athens Agios Savvas	Athens
Greece	General Oncology Hospital of Kifisias "Agioi Anargyroi	Athens
Greece	University Hospital of Heraklion	Heraklion
Greece	'Papageorgiou' General Hospital of Thessaloniki	Thessaloniki
Spain	Hosp. Univ. A Coruna	A Coruna
Spain	Hosp. Torrecardenas	Almería
Spain	Hosp. Puerta Del Mar	Cádiz
Spain	Hosp. Gral. Univ. de Castellon	Castellon
Spain	Hosp. Univ. de Canarias	La Laguna
Spain	Hosp. Univ. Lucus Augusti	Lugo
Spain	Hosp. Regional Univ. de Malaga	Malaga
Spain	Hosp. Clinico Univ. de Santiago	Santiago de Compostela
Spain	Hosp. Univ. I Politecni La Fe	Valencia
United Kingdom	Frimley Health NHS Foundation Trust	Berkshire
United Kingdom	Torbay Hospital-Devon	Devon
United Kingdom	Royal Surrey County Hospital NHS Trust	Guildford
United Kingdom	Pennine Care Nhs Foundation Trust	Oldham
United Kingdom	Scunthorpe General Hospital	Scunthorpe

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Countries where clinical trial is conducted

Austria,  France,  Germany,  Greece,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3	Percentage of participants with PSA level less than (<)0.2 nanogram per milliliter (ng/mL) at month 3 will be reported.	At month 3
Primary	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	HRQoL of the participants will be assessed as partial EORTC QLQ-C30 questionnaire. EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom.	Up to 30 Months
Primary	Cognitive Functioning as Assessed by Partial Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire	Cognitive function of the participants will be measured by the partial FACT-Cog (Version 3) questionnaire. The FACT-Cog score ranges from scale 0-148. The higher the total score, the better the cognitive function.	Up to 30 Months
Primary	Fatigue as Assessed by Brief Fatigue Inventory-Short Form (BFI-SF) Questionnaire	Participant fatigue will be assessed by the BFI-SF questionnaire. The BFI-SF score range from scale 0-10. Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).	Up to 30 Months
Primary	Prostate-specific Antigen (PSA) Anxiety as Assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire	PSA anxiety of the participant will be assessed by the MAX-PC questionnaire. The MAX-PC total score ranges from scale 0 to 54. The MAX-PC is divided into three subscales: a) prostate cancer anxiety (PCA) range from 0 to 33, b) Prostate-Specific Antigen Anxiety (PSAA) ranges from 0 to 9, and c) fear of recurrence (FOR) ranges from 0 to 12.	Up to 30 Months