A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France

Adherent participants are defined as participants adherent to apalutamide at every visit until 12 months according to the Medication Adherence Report Scale (MARS-5). MARS-5 is a well-known participant-reported adherence measure (PRAM) consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.

Participants with changes in adherence according to the MARS-5, by apalutamide formulation will be reported. MARS-5 is a well-known PRAM consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.

Clinical risk factors for treatment the Eastern Cooperative Oncology Group (ECOG) will be reported.

Clinical risk factors for treatment prostate comorbidities will be reported.

Predictive clinical factors of adherence that is disease volume at 12 months will be reported.

Percentage of adherent participants at 3 months, 6 months and 9 months according to the MARS-5 will be reported. MARS-5 is a well-known PRAM consisting of 5 items assessing the adherence behavior of a participant to a given medication. Participants are asked to evaluate how often they adopt each behavior with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.

Participants with changes in adherence according to the MARS-5, by apalutamide formulation will be reported. MARS-5 is a well-known PRAM consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.

SPUR is a validated, participant-reported questionnaire that assesses adherence-related behavior across thirteen specific behavioral drivers categorized into four dimensions: Social, Psychological, Usage, and Rational. It consists of 24 items and uses a 5-point Likert scale for each item (ranging from "strongly disagree" to "strongly agree"), with some items reverse-coded to minimize response bias. Scores are calculated for each behavioral driver dimension and score indicating the risk of non-adherence is calculated from them, allowing assessment of global non-adherence risk as well as analysis of the behavioral constituents of that risk by considering the mix of drivers present and their relative importance. Here, higher scores indicate more adherence.

Spearman correlation coefficients between each of the 13 behavioral drivers will be reported.

SPUR is a validated, participant-reported questionnaire that assesses adherence-related behavior across thirteen specific behavioral drivers categorized into four dimensions: Social, Psychological, Usage, and Rational. It consists of 24 items and uses a 5-point Likert scale for each item (ranging from "strongly disagree" to "strongly agree"), with some items reverse-coded to minimize response bias. Scores are calculated for each behavioral driver dimension and score indicating the risk of non-adherence is calculated from them, allowing assessment of global non-adherence risk as well as analysis of the behavioral constituents of that risk by considering the mix of drivers present and their relative importance. Here, higher scores indicate more adherence.

The FACT-P questionnaire is used to assess quality of life (QoL) in men undergoing therapy for prostate cancer. It is composed of 39 items using a 5-point Likert-like scale. Each item is rated on a 0 to 4, and then combined to produce subscale scores, as well as a global QoL score. Higher scores represent better QoL.

The FACT-P questionnaire is used to assess quality of life in men undergoing therapy for prostate cancer. It is composed of 39 items using a 5-point Likert-like scale. Each item is rated on a 0 to 4 , and then combined to produce subscale scores, as well as a global QoL score. Higher scores represent better QoL.

The demographic characteristics of participants that is, age will be reported.

The demographic characteristics of participants that is, socio-professional category (the participant's last occupation held prior to retirement: Managerial [higher managerial or lower managerial], Non-managerial [intermediate or small employers or lower supervisory or semi-routine or routine], Never worked or long-term unemployed will be reported.

The demographic characteristics of participants that is, G8 geriatric screening score will be reported. The G8 consists of eight items: participant age (greater than [>]85, 80-85, less than [<]80), and seven items from the original 18-item MNA (Mini Nutritional Assessment: appetite changes, weight loss, mobility, neuropsychological problems, body mass index, medication, and self-rated health). The total score ranges from 0 to 17, with higher scores indicating a lower risk of impairments.

PSA levels at ADT initiation will be reported.

PSA levels at baseline will be reported.

Change from baseline in PSA levels will be reported.

Serum testosterone levels will be reported.

Time from initial diagnosis of prostate cancer to metastatic stage for metachronous participants will be reported.

Number of participants with different type of imaging methods used for cancer diagnostic (for example, magnetic resonance imaging [MRI], Prostate Specific Membrane Antigen Positron Emission Tomography [PSMA-PET], Positron emission tomography [PET] choline, Computed Tomography scan [CT scan], bone scan) will be reported.

Osteodensitometry score, a type of imaging method used for cancer diagnostic will be reported.

Location of metastases as assessed by bone and CT/MRI scans, PSMA-PET scans and any other imaging methods documented in routine practice will be recorded.

Number of lesions as assessed by bone and CT/MRI scans, PSMA-PET scans and any other imaging methods documented in routine practice will be recorded.

ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead.

Participants with history of treatment for prostate cancer will be reported.

Participants with Current concomitant diseases (co-morbidities) will be reported.

Participants with relevant vital sign assessment (blood pressure and pulse) will be reported.

Time from mHSPC diagnosis to treatment initiation is defined as the time between date of mHSPC diagnosis and first administration of apalutamide.

Percentage of participants with undetectable PSA levels that is PSA level less than or equal to (<=) 0.2 nanogram per milliliter (ng/mL) will be reported.

Percentage of participants with ultralow PSA levels that is PSA level <= 0.02 ng/mL will be reported.

Time to undetectable PSA is defined as the time between first administration of apalutamide and date of undetectable PSA.

Time to UL PSA is defined as the time between first administration of apalutamide and date of UL PSA.

Participants with >=50% reduction in PSA value from baseline will be reported.

Participants with >=90% reduction in PSA value from baseline will be reported.

Participants with decrease in PSA levels (PSA halving-time) over time will be reported.

PFS is defined as the time from initiation of apalutamide until earliest record of disease progression determined by physician's assessment, or death.

The number of deaths at months 3,6,9 and 12 will be reported.

Participants reporting changes since baseline in Apalutamide and ADT Modalities (that is, dose, route of administration, number of tablets, time of intake) will be reported.

Time from mHSPC diagnosis to ADT treatment initiation will be reported.

Time between ADT and apalutamide initiation will be reported.

Participants who have discontinued apalutamide treatment will be reported.

Participants who have discontinued apalutamide treatment and the reasons for discontinuation will be reported.

Time to discontinuation of apalutamide treatment will be reported.

Participants receiving planned subsequent treatment for prostate cancer will be reported.

The percentage of participants who consulted for treatment will be reported.

Percentage of participants who use caregiver support will be reported.

Participants receiving concomitant treatments will be reported.

Participants with a change in concomitant treatments will be reported.

An adverse event is any untoward medical occurrence in a participant administered a medicinal product. An adverse event does not necessarily have a causal relationship with the treatment. A serious adverse event is any untoward medical occurrence that at any dose: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is a suspected transmission of any infectious agent via a medicinal product or is medically important. Severity of AEs will be graded as follows: Mild (Easily tolerated symptoms), Moderate (Sufficient discomfort, causes interference with normal activity) and Severe (Extreme distress).

Percentage of undetectable PSA according to adherence levels, that is PSA level <= 0.2 ng/mL will be reported.

Percentage of UL PSA according to adherence levels, that is PSA level <= 0.02 ng/mL will be reported.

Participants with >=50% reduction in PSA value from baseline according to adherence levels will be reported.

Participants with >=90% reduction in PSA value from baseline according to adherence levels will be reported.

Participants using the concomitant treatments will be reported.

Clinical risk factors for prostate specific antigen (PSA) rate will be reported.

Participants with socio-professional category will be reported.

Participants reporting the use of disease specialized consultations will be reported.