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An OBServational Prospective Study in France: Adherence to APAlutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in France

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre Francois Baclesse
RECRUITING
Caen
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-12-18
Estimated Completion Date: 2028-01-03
Participants
Target number of participants: 270
Treatments
Metastatic hormone-sensitive prostate cancer (mHSPC): Routine Clinical Practice Setting
Participants with confirmed diagnosis of mHSPC will be enrolled at the time of initiation of treatment with apalutamide (Month 0) in routine clinical practice and will be followed up until 12 months after end of study visit (Month 12). No intervention will be administered as a part of this study.
Related Therapeutic Areas
Sponsors
Leads: Janssen Cilag S.A.S.

This content was sourced from clinicaltrials.gov