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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Metastatic Hormone-sensitive Prostate Cancer

Intervention / Treatment
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* Drug: Apalutamide
* Drug: Enzalutamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Apalutamide Plus Androgen Deprivation Therapy (ADT)<br>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<br>* No interventions will be administered as a part of this study. Participants will receive apalutamide as per their routine clinical practice.<br>* Other names: ERLEADA;|
| Enzalutamide Plus Androgen Deprivation Therapy (ADT)<br>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<br>* No interventions will be administered as a part of this study. Participants will receive enzalutamide as per their routine clinical practice.<br>* Other names: XTANDI;|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 |