Metastatic Hormone-sensitive Prostate Cancer
Conditions
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).
Interventions
DRUGApalutamide
No interventions will be administered as a part of this study. Participants will receive apalutamide as per their routine clinical practice.
DRUGEnzalutamide
No interventions will be administered as a part of this study. Participants will receive enzalutamide as per their routine clinical practice.
Sponsors
Janssen-Cilag Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
Countries
Austria, France, Germany, Greece, Spain, United Kingdom
Contacts
STUDY_DIRECTORJanssen-Cilag Ltd Clinical Trial
Janssen-Cilag Ltd.
Outcome results
None listed