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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

Study acronym: RE-ENGAGE
StatusCompleted
PhaseNot specified
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Final enrollment: 477 participants (planned 700) · Primary completion date changed from estimate of Dec 31, 2026 to Jun 30, 2026 · Secondary endpoints: details revised at 15 of 18 entries · 1 more Show 4 more changesShow less
    • Final enrollment: 477 participants (planned 700)
    • Primary completion date changed from estimate of Dec 31, 2026 to Jun 30, 2026
    • Secondary endpoints: details revised at 15 of 18 entries
    • Eligibility criteria expanded, about 5 words
  2. 6 versions Re-verified since May 12, 2025, no change to tracked fieldsv3-v8
  3. Secondary endpoints revised (18)v2 See this version in full on ClinicalTrials.gov ↗
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Bayer
131 trials monitored
See 7 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
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.
Trial Details
NCT Number NCT06874114
Lead Sponsor Bayer
Conditions Metastatic Hormone-sensitive Prostate Cancer
Enrollment 477 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov