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

Sponsor
Janssen-Cilag Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05901649
Collaborator
(none)
450
Enrollment
43
Locations
26.7
Anticipated Duration (Months)
10.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
450 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Anticipated Study Start Date :
Jun 14, 2023
Anticipated Primary Completion Date :
Sep 5, 2025
Anticipated Study Completion Date :
Sep 5, 2025

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3 [At month 3]

      Percentage of participants with PSA level less than (<)0.2 nanogram per milliliter (ng/mL) at month 3 will be reported.

    2. 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 [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.

    3. Cognitive Functioning as Assessed by Partial Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire [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.

    4. Fatigue as Assessed by Brief Fatigue Inventory-Short Form (BFI-SF) Questionnaire [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).

    5. Prostate-specific Antigen (PSA) Anxiety as Assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medizinische Universität Innsbruck Innsbruck Austria 6020
    2 Krems University Hospital Krems an der Donau Austria 3500
    3 Klinikum Wels-Grieskirchen Wels Austria 4600
    4 Akh Wien Wien Austria 1090
    5 Institut Sainte Catherine Avignon France 84918
    6 Institut Bergonié Bordeaux France 33000
    7 Polyclinique Bordeaux Nord Acquitaine Bordeaux France 33077
    8 Clinique Pasteur- Lanroze Brest France 29229
    9 Centre d'oncologie de Gentilly Nancy France 54100
    10 CHU Nîmes Nimes France 30029
    11 Clinique de la Croix du Sud Quint-Fonsegrives France 31130
    12 Centre Hospitalier Prive Saint-Grégoire France 35760
    13 Hopital Foch Suresnes France 92150
    14 CHU de Toulouse Toulouse cedex 9 France 31059
    15 Ulrich Kube - Germany Chemnitz Germany 09119
    16 Urologicum Duisburg Duisburg Germany 47169
    17 Urologisches Zentrum Mittelhessen Gladenbach Germany 35075
    18 Praxis Dr. Serkan Filiz Hamburg Germany 22880
    19 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Germany 55131
    20 Universitaetsklinikum Muenster Muenster Germany 48149
    21 Urologisches Zentrum am Boxberg GP Derout/Pönicke/Becker - Germany Neunkirchen Germany 66538
    22 General Hospital of Athens 'G. Gennimatas' Athens Greece 115 27
    23 Anticancer Oncology Hospital of Athens Agios Savvas Athens Greece 11522
    24 Attikon University General Hospital of Attica Athens Greece 12462
    25 Alexandra General Hospital of Athens Athina Greece 115 28
    26 University Hospital of Heraklion Heraklion Greece 71110
    27 University General Hospital of Rio Patras Patras Greece 26504
    28 Anticancer Hospital of Thessaloniki 'Theageneio' Thessaloniki Greece 546 39
    29 'Papageorgiou' General Hospital of Thessaloniki Thessaloniki Greece TK 56403
    30 Hosp. Univ. A Coruña A Coruña Spain 15006
    31 Hosp. Torrecardenas Almería Spain 04009
    32 Hosp. Gral. Univ. De Castellon Castellon Spain 12004
    33 Hosp. Puerta Del Mar Cádiz Spain 11009
    34 Hosp. Univ. de Canarias La Laguna Spain 38320
    35 Hosp. Univ. Lucus Augusti Lugo Spain 27003
    36 Hosp. Regional Univ. de Malaga Malaga Spain 29010
    37 Hosp. Clinico Univ. de Santiago Santiago de Compostela Spain 15706
    38 Hosp. Univ. I Politecni La Fe Valencia Spain 46026
    39 Frimley Health NHS Foundation Trust Berkshire United Kingdom SL2 4HL
    40 Torbay Hospital-Devon Devon United Kingdom TQ2 7AA
    41 Royal Surrey County Hospital NHS Trust Guildford United Kingdom GU2 7XX
    42 Royal Free London NHS Foundation Trust London United Kingdom NW3 2QG
    43 Pennine Care Nhs Foundation Trust Oldham United Kingdom OL1 2JH

    Sponsors and Collaborators

    • Janssen-Cilag Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen-Cilag Ltd.
    ClinicalTrials.gov Identifier:
    NCT05901649
    Other Study ID Numbers:
    • CR109320
    • 56021927PCR4031
    First Posted:
    Jun 13, 2023
    Last Update Posted:
    Jun 13, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Hypersensitivity

    Study Results

    No Results Posted as of Jun 13, 2023