A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorJanssen Cilag S.A.S.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult male (according to their chromosomal composition at birth) participants with confirmed diagnosis of mHSPC will be enrolled at the time of initiation of treatment with apalutamide.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
540 Participants
are grouped into 1 trial groupGroup A: Metastatic hormone-sensitive prostate cancer (mHSPC): Routine Clinical Practice Setting
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov