NCT06874114

An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadian Men With Metastatic Hormone Sensitive Prostate Cancer in Routine Medical Care

REal-world EvideNce Study describinG treAtment Intensification Patterns amonG Canadian patiEnts With mHSPC Using EHR Data From Community Urology Clinics

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: —

Summary

This is an observational study in which only data are collected from adult Canadian men with metastatic hormone sensitive prostate cancer (mHSPC) are studied. Participants will not receive any advice on treatment or any changes to the healthcare. Metastatic hormone sensitive prostate cancer is a cancer of the prostate gland, a male reproductive gland found below the bladder. Metastatic means that cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with anti-hormonal therapy such as androgen deprivation therapy (ADT). ADT lowers the level of testosterone and slows down the growth of cancer cells. However, in some cases, ADT alone is not sufficient and doctors recommend combining it with treatments like Androgen Receptor Pathway Inhibitors (ARPi) and/or docetaxel to stop the growth of cancer cells. ARPi slow down the growth of the cancer cells by blocking a sex hormone called the androgens from attaching to the protein found in the cancer cells. ARPi includes medicines like apalutamide, darolutamide, and enzalutamide. Docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells. ADT, ARPi, and docetaxel are approved treatments for men with mHSPC in Canada. The participants in this study are already receiving treatment for mHSPC as part of their routine medical care from their doctors.

Conditions

• Metastatic Hormone-sensitive Prostate Cancer

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-03-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Canada