Metastatic Hormone-sensitive Prostate Cancer, Prostatic Neoplasms
Conditions
Keywords
Apalutamide, mHSPC
Brief summary
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.
Interventions
None listed
Sponsors
Janssen Cilag S.A.S.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation | At 12 months | 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. |
| Percentage of Participants With Adherence to Apalutamide at 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | At Months 3,6,9,12 | PFS is defined as the time from initiation of apalutamide until earliest record of disease progression determined by physician's assessment, or death. |
| Number of Deaths | At Months 3,6,9,12 | The number of deaths at months 3,6,9 and 12 will be reported. |
| Number of Participants Reporting Change Since Baseline in Apalutamide and ADT Modalities | At Baseline, Months 3,6,9,12 | 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 | Baseline up to Month 12 | Time from mHSPC diagnosis to ADT treatment initiation will be reported. |
| Time Between ADT and Apalutamide Treatment Initiation | Baseline up to Month 12 | Time between ADT and apalutamide initiation will be reported. |
| Number of Participants with Apalutamide Treatment Discontinuation | At Months 3,6,9,12 | Participants who have discontinued apalutamide treatment will be reported. |
| Reasons for Discontinuation of Apalutamide Treatment | At Months 3,6,9,12 | Participants who have discontinued apalutamide treatment and the reasons for discontinuation will be reported. |
| Time to Discontinuation of Apalutamide Treatment | At Months 3,6,9,12 | Time to discontinuation of apalutamide treatment will be reported. |
| Number of Participants Receiving Planned Subsequent Treatment for Prostate Cancer | At Months 3,6,9,12 | Participants receiving planned subsequent treatment for prostate cancer will be reported. |
| Percentage of Participants who Consulted for Treatment | At Months 3,6,9,12 | The percentage of participants who consulted for treatment will be reported. |
| Percentage of Participants who Used Caregiver Support | At Months 3,6,9,12 | Percentage of participants who use caregiver support will be reported. |
| Number of Participants Receiving Concomitant Treatments | At Baseline, Months 3,6,9,12 | Participants receiving concomitant treatments will be reported. |
| Number of Participants with a Change in Concomitant Treatments | At Months 3,6,9,12 | Participants with a change in concomitant treatments will be reported. |
| Clinical Risk Factor Among Adherent and Non-adherent Participants: ECOG Status | Up to 12 months | Clinical risk factors for treatment the Eastern Cooperative Oncology Group (ECOG) will be reported. |
| Clinical Risk Factor Among Adherent and Non-adherent Participants: Comorbidities | Up to 12 months | Clinical risk factors for treatment prostate comorbidities will be reported. |
| Clinical Factors of Adherence at 12 Months: Disease Volume | At 12 months | Predictive clinical factors of adherence that is disease volume at 12 months will be reported. |
| Percentage of Adherent Participants at 3, 6, and 9 Months | At 3,6,9 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. |
| Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation at 3, 6 and 9 Months | At 3, 6 and 9 months | 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. |
| Number of Participants with Risk of Non-Adherence as per Social, Psychological, Usage and Rational (SPUR) Factors as per SPUR Adherence Tool | Baseline, Months 3, 6, 9 and 12 | 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. |
| SPUR Global Risk Score at Baseline and Month 12 | At Baseline and Month 12 | 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. |
| Functional Assessment of Cancer Therapy- Prostate (FACT-P) Score | At Baseline, Months 3, 6, 9, 12 | 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. |
| Change from Baseline in FACT-P Score at 3, 6 and 9 Months | Baseline, Months 3, 6, 9, 12 | 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. |
| Demographics Characteristics of Participants: Age | Baseline | The demographic characteristics of participants that is, age will be reported. |
| Demographics Characteristics of Participants: Socio-Professional Category | Baseline | 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. |
| Demographics Characteristics of Participants: G8 Geriatric Screening Score | Baseline | 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. |
| Prostate-Specific Antigen (PSA) Level at Androgen-Deprivation Therapy (ADT) Initiation | Up to 12 months | PSA levels at ADT initiation will be reported. |
| PSA Level at Baseline | At Baseline | PSA levels at baseline will be reported. |
| Change from Baseline in PSA Levels | Baseline up to 12 months | Change from baseline in PSA levels will be reported. |
| Serum Testosterone at Baseline | At baseline | Serum testosterone levels will be reported. |
| Time from Initial Diagnosis of Prostate Cancer to Metastatic Stage | Baseline up to 12 months | Time from initial diagnosis of prostate cancer to metastatic stage for metachronous participants will be reported. |
| Type of Imaging Methods Used for Cancer Diagnostics | Baseline | 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 | Baseline | Osteodensitometry score, a type of imaging method used for cancer diagnostic will be reported. |
| Tumor assessment: Location of Metastases | Baseline | 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. |
| Tumor assessment: Number of Lesions | Baseline | 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 Performance Status | At Baseline | 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. |
| Number of Participants with History of Treatment for Prostate Cancer | Baseline | Participants with history of treatment for prostate cancer will be reported. |
| Number of Participants Reporting Concomitant Diseases | Baseline | Participants with Current concomitant diseases (co-morbidities) will be reported. |
| Number of Participants With Vital Sign Assessments | Baseline | Participants with relevant vital sign assessment (blood pressure and pulse) will be reported. |
| Time from Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Diagnosis to Treatment Initiation | Baseline up to 12 months | 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 Reaching Undetectable PSA | At Months 3,6,9,12 | 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 Reaching Ultralow (UL) PSA | At Months 3,6,9,12 | Percentage of participants with ultralow PSA levels that is PSA level \<= 0.02 ng/mL will be reported. |
| Time to Undetectable PSA | Up to 12 months | Time to undetectable PSA is defined as the time between first administration of apalutamide and date of undetectable PSA. |
| Time to UL PSA | Up to 12 months | Time to UL PSA is defined as the time between first administration of apalutamide and date of UL PSA. |
| Number of Participants with Greater Than or Equal to (>=) 50% Decline in PSA Values (PSA 50) from Baseline | Baseline up to 12 months | Participants with \>=50% reduction in PSA value from baseline will be reported. |
| Number of Participants with >= 90% Decline in PSA Values (PSA 90) from Baseline | Baseline up to 12 months | Participants with \>=90% reduction in PSA value from baseline will be reported. |
| Number of Participants Experiencing At Least One Adverse Event (AE) | At Months 3,6,9,12 | 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 | At Months 3,6,9,12 | 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 | At Months 3,6,9,12 | Percentage of UL PSA according to adherence levels, that is PSA level \<= 0.02 ng/mL will be reported. |
| Number of Participants with PSA 50 Response According to Adherence Levels | At Months 3,6,9, and 12 | Participants with \>=50% reduction in PSA value from baseline according to adherence levels will be reported. |
| Number of Participants with PSA 90 Response According to Adherence Levels | At Months 3,6,9, and 12 | Participants with \>=90% reduction in PSA value from baseline according to adherence levels will be reported. |
| Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Use of Concomitant Treatments | Up to 12 months | Participants using the concomitant treatments will be reported. |
| Clinical Risk Factor Among Adherent and Non-adherent Participants: Prostate Specific Antigen (PSA) Rate | Up to 12 months | Clinical risk factors for prostate specific antigen (PSA) rate will be reported. |
| Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Socio-professional Category | Up to 12 months | Participants with socio-professional category will be reported. |
| Spearman Correlation Coefficients at Baseline and Month 12 | At Baseline and Month 12 | Spearman correlation coefficients between each of the 13 behavioral drivers will be reported. |
| Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Use of Disease Specialized Consultations | Up to 12 months | Participants reporting the use of disease specialized consultations will be reported. |
| Number of Participants with Decrease in PSA Levels (PSA Halving-time) | Up to 12 months | Participants with decrease in PSA levels (PSA halving-time) over time will be reported. |
Countries
France
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen-Cilag France Clinical Trial
Janssen-Cilag France
Outcome results
None listed