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

March 25, 2024 updated by: Janssen-Cilag Ltd.

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Wels, Austria, 4600
        • Recruiting
        • Klinikum Wels-Grieskirchen
      • Wien, Austria, 1090
        • Recruiting
        • Akh Wien
  • France
      • Avignon, France, 84918
        • Recruiting
        • Institut Sainte Catherine
      • Bordeaux, France, 33000
        • Recruiting
        • Institut Bergonie
      • Bordeaux, France, 33077
        • Recruiting
        • Polyclinique Bordeaux Nord Acquitaine
      • Brest, France, 29229
        • Recruiting
        • Clinique Pasteur- Lanroze
      • Lyon, France, 69003
        • Recruiting
        • Hôpital Edouard Herriot
      • Nancy, France, 54100
        • Recruiting
        • Centre d'oncologie de Gentilly
      • Nimes, France, 30029
        • Recruiting
        • Chu Nimes
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges-Pompidou
      • Quint-Fonsegrives, France, 31130
        • Recruiting
        • Clinique de la Croix du Sud
      • Saint-Grégoire, France, 35760
        • Recruiting
        • Centre Hospitalier Prive
      • Suresnes, France, 92150
        • Recruiting
        • Hôpital FOCH
      • Toulouse cedex 9, France, 31059
        • Recruiting
        • CHU de Toulouse
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • St. Elisabeth Hospital Leipzig
      • Duisburg, Germany, 47169
        • Recruiting
        • Urologicum Duisburg
      • Gladenbach, Germany, 35075
        • Recruiting
        • Urologisches Zentrum Mittelhessen
      • Hamburg, Germany, 22880
        • Completed
        • Praxis Dr. Serkan Filiz
      • Mainz, Germany, 55131
        • Recruiting
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Muenster, Germany, 48149
        • Recruiting
        • Universitaetsklinikum Muenster
  • Greece
      • Athens, Greece, 11522
        • Recruiting
        • Anticancer Oncology Hospital of Athens Agios Savvas
      • Heraklion, Greece, 71110
        • Recruiting
        • University Hospital of Heraklion
      • Thessaloniki, Greece, TK 56403
        • Recruiting
        • 'Papageorgiou' General Hospital of Thessaloniki
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Hosp. Univ. A Coruna
      • Almería, Spain, 04009
        • Recruiting
        • Hosp. Torrecardenas
      • Castellon, Spain, 12004
        • Recruiting
        • Hosp. Gral. Univ. de Castellon
      • Cádiz, Spain, 11009
        • Recruiting
        • Hosp. Puerta Del Mar
      • La Laguna, Spain, 38320
        • Recruiting
        • Hosp. Univ. de Canarias
      • Lugo, Spain, 27003
        • Recruiting
        • Hosp. Univ. Lucus Augusti
      • Malaga, Spain, 29010
        • Recruiting
        • Hosp. Regional Univ. de Malaga
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hosp. Clinico Univ. de Santiago
      • Valencia, Spain, 46026
        • Recruiting
        • Hosp. Univ. I Politecni La Fe
  • United Kingdom
      • Berkshire, United Kingdom, SL2 4HL
        • Recruiting
        • Frimley Health NHS Foundation Trust
      • Devon, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay Hospital-Devon
      • Guildford, United Kingdom, GU2 7XX
        • Recruiting
        • Royal Surrey County Hospital NHS Trust
      • Oldham, United Kingdom, OL1 2JH
        • Recruiting
        • Pennine Care NHS Foundation Trust
      • Scunthorpe, United Kingdom, DN15 7BH
        • Recruiting
        • Scunthorpe General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 before 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 more than 2 months prior to apalutamide or enzalutamide treatment initiation
  • Has received prior immediate docetaxel for the treatment of mHSPC
  • Participants is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Apalutamide
No interventions will be administered as a part of this study. Participants will receive apalutamide as per their routine clinical practice.
Other Names:
  • ERLEADA
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.
Drug: Enzalutamide
No interventions will be administered as a part of this study. Participants will receive enzalutamide as per their routine clinical practice.
Other Names:
  • XTANDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3
Time Frame: 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
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
Time Frame: Up to 30 Months
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
Cognitive Functioning as Assessed by Partial Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire
Time Frame: Up to 30 Months
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
Fatigue as Assessed by Brief Fatigue Inventory-Short Form (BFI-SF) Questionnaire
Time Frame: Up to 30 Months
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
Prostate-specific Antigen (PSA) Anxiety as Assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire
Time Frame: Up to 30 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Ltd.

Investigators

  • Study Director: Janssen-Cilag Ltd Clinical Trial, Janssen-Cilag Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2023

Primary Completion (Estimated)

September 5, 2025

Study Completion (Estimated)

September 5, 2025

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR109320
  • 56021927PCR4031 (Other Identifier: Janssen-Cilag Ltd)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Hormone-sensitive Prostate Cancer

Clinical Trials on Apalutamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe