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

Janssen Cilag S.A.S.270 enrolled

Overview

This study aims to explore the real-world treatment adherence, persistence of apalutamide, and assess the risk of non-adherence according to the participant's profile and behavior of metastatic hormone-sensitive prostate cancer (mHSPC) participants treated with apalutamide during the first year of continued treatment.

Study Type

OBSERVATIONAL

Enrollment

270

Conditions

Prostatic Neoplasms Metastatic Hormone-sensitive Prostate Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Male (based on chromosomal composition at birth) and aged greater than or equal to (\>=) 18 years. * Must have a histologically or cytologically confirmed diagnosis of prostate adenocarcinoma * Must have documented metastatic hormone-sensitive prostate cancer (mHSPC) * Must have agreed with the treating physician to initiate treatment with apalutamide (plus androgen-deprivation therapy \[ADT\]) in accordance with the current product characteristics summary, based on the physician's decision, prior to study inclusion * Able to understand the content of the patient information sheet and has provided oral consent for data collection. Has received the information sheet and has not objected to data collection * Must have a baseline prostate-specific antigen (PSA) level collected prior to the first administration of apalutamide. * Must agree to complete adherence and quality-of-life questionnaires during the study, including before the first administration of apalutamide Exclusion criteria: * Has already received or is currently receiving apalutamide, or any other androgen receptor pathway inhibitor (ARPI; including but not limited to abiraterone acetate, darolutamide, and enzalutamide) or chemotherapy for mHSPC * Has received an investigational drug (including vaccines) or used an invasive investigational medical device within 90 days prior to study start or data collection * Is currently receiving active treatment for prostate cancer as part of an interventional study * Has received ADT for mHSPC for more than 4 months prior to starting apalutamide treatment * Has experienced progression under ADT (and thus became castration-resistant) before starting apalutamide treatment * Beneficiary of State Medical Aid \[AME\] * Does not speak/read French * Under guardianship or curatorship * Under judicial protection

Locations (1)

Centre Francois Baclesse

Caen, France

RECRUITING

Outcomes

Primary Outcomes

Percentage of Participants With Adherence to Apalutamide at 12 Months

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.

Time frame: At 12 months

Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation

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.

Time frame: At 12 months

Secondary Outcomes

Clinical Risk Factor Among Adherent and Non-adherent Participants: ECOG Status

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

Time frame: Up to 12 months

Clinical Risk Factor Among Adherent and Non-adherent Participants: Comorbidities

Clinical risk factors for treatment prostate comorbidities will be reported.

Time frame: Up to 12 months

Clinical Factors of Adherence at 12 Months: Disease Volume

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

Time frame: At 12 months

Central Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Percentage of Adherent Participants at 3, 6, and 9 Months

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.

Time frame: At 3,6,9 months

Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation at 3, 6 and 9 Months

Time frame: At 3, 6 and 9 months

Number of Participants with Risk of Non-Adherence as per Social, Psychological, Usage and Rational (SPUR) Factors as per SPUR Adherence Tool

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.

Time frame: Baseline, Months 3, 6, 9 and 12

Spearman Correlation Coefficients at Baseline and Month 12

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

Time frame: At Baseline and Month 12

SPUR Global Risk Score at Baseline and Month 12

Time frame: At Baseline and Month 12

Functional Assessment of Cancer Therapy- Prostate (FACT-P) Score

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.

Time frame: At Baseline, Months 3, 6, 9, 12

Change from Baseline in FACT-P Score at 3, 6 and 9 Months

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.

Time frame: Baseline, Months 3, 6, 9, 12

Demographics Characteristics of Participants: Age

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

Time frame: Baseline

Demographics Characteristics of Participants: Socio-Professional Category

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.

Time frame: Baseline

Demographics Characteristics of Participants: G8 Geriatric Screening Score

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.

Time frame: Baseline

Prostate-Specific Antigen (PSA) Level at Androgen-Deprivation Therapy (ADT) Initiation

PSA levels at ADT initiation will be reported.

Time frame: Up to 12 months

PSA Level at Baseline

PSA levels at baseline will be reported.

Time frame: At Baseline

Change from Baseline in PSA Levels

Change from baseline in PSA levels will be reported.

Time frame: Baseline up to 12 months

Serum Testosterone at Baseline

Serum testosterone levels will be reported.

Time frame: At baseline

Time from Initial Diagnosis of Prostate Cancer to Metastatic Stage

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

Time frame: Baseline up to 12 months

Type of Imaging Methods Used for Cancer Diagnostics

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.

Time frame: Baseline

Osteodensitometry Score

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

Time frame: Baseline

Tumor assessment: Location of Metastases

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.

Time frame: Baseline

Tumor assessment: Number of Lesions

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.

Time frame: Baseline

ECOG Performance Status

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.

Time frame: At Baseline

Number of Participants with History of Treatment for Prostate Cancer

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

Time frame: Baseline

Number of Participants Reporting Concomitant Diseases

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

Time frame: Baseline

Number of Participants With Vital Sign Assessments

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

Time frame: Baseline

Time from Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Diagnosis to Treatment Initiation

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

Time frame: Baseline up to 12 months

Percentage of Participants Reaching Undetectable PSA

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.

Time frame: At Months 3,6,9,12

Percentage of Participants Reaching Ultralow (UL) PSA

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

Time frame: At Months 3,6,9,12

Time to Undetectable PSA

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

Time frame: Up to 12 months

Time to UL PSA

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

Time frame: Up to 12 months

Number of Participants with Greater Than or Equal to (>=) 50% Decline in PSA Values (PSA 50) from Baseline

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

Time frame: Baseline up to 12 months

Number of Participants with >= 90% Decline in PSA Values (PSA 90) from Baseline

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

Time frame: Baseline up to 12 months

Number of Participants with Decrease in PSA Levels (PSA Halving-time)

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

Time frame: Up to 12 months

Progression-Free Survival (PFS)

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

Time frame: At Months 3,6,9,12

Number of Deaths

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

Time frame: At Months 3,6,9,12

Number of Participants Reporting Change Since Baseline in Apalutamide and ADT Modalities

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 frame: At Baseline, Months 3,6,9,12

Time from mHSPC Diagnosis to ADT Treatment Initiation

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

Time frame: Baseline up to Month 12

Time Between ADT and Apalutamide Treatment Initiation

Time between ADT and apalutamide initiation will be reported.

Time frame: Baseline up to Month 12

Number of Participants with Apalutamide Treatment Discontinuation

Participants who have discontinued apalutamide treatment will be reported.

Time frame: At Months 3,6,9,12

Reasons for Discontinuation of Apalutamide Treatment

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

Time frame: At Months 3,6,9,12

Time to Discontinuation of Apalutamide Treatment

Time to discontinuation of apalutamide treatment will be reported.

Time frame: At Months 3,6,9,12

Number of Participants Receiving Planned Subsequent Treatment for Prostate Cancer

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

Time frame: At Months 3,6,9,12

Percentage of Participants who Consulted for Treatment

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

Time frame: At Months 3,6,9,12

Percentage of Participants who Used Caregiver Support

Percentage of participants who use caregiver support will be reported.

Time frame: At Months 3,6,9,12

Number of Participants Receiving Concomitant Treatments

Participants receiving concomitant treatments will be reported.

Time frame: At Baseline, Months 3,6,9,12

Number of Participants with a Change in Concomitant Treatments

Participants with a change in concomitant treatments will be reported.

Time frame: At Months 3,6,9,12

Number of Participants Experiencing At Least One Adverse Event (AE)

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).

Time frame: At Months 3,6,9,12

Percentage of Undetectable PSA According to Adherence Levels

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

Time frame: At Months 3,6,9,12

Percentage of UL PSA According to Adherence Levels

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

Time frame: At Months 3,6,9,12

Number of Participants with PSA 50 Response According to Adherence Levels

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

Time frame: At Months 3,6,9, and 12

Number of Participants with PSA 90 Response According to Adherence Levels

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

Time frame: At Months 3,6,9, and 12

Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Use of Concomitant Treatments

Participants using the concomitant treatments will be reported.

Time frame: Up to 12 months

Clinical Risk Factor Among Adherent and Non-adherent Participants: Prostate Specific Antigen (PSA) Rate

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

Time frame: Up to 12 months

Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Socio-professional Category

Participants with socio-professional category will be reported.

Time frame: Up to 12 months

Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Use of Disease Specialized Consultations

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

Time frame: Up to 12 months