Trial Condition(s):
Metastatic hormone-sensitive prostate cancer
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 (RE-ENGAGE)
Bayer Identifier:
22917
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Men aged ≥ 18 years diagnosed with mHSPC verified by radiographic evidence of metastasis with Conventional Imaging (CI) or Prostate Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET), and histologically confirmed carcinoma - At least 6 months follow-up post-diagnosis period, unless the patient died earlier
Exclusion Criteria
- ADT use for >6 months or any use of ARPi (ADT use in the neoadjuvant or adjuvant setting where the patient has been off treatment for 12 months or more is allowed)
- This criterion is to ensure that we are capturing mHSPC patients and not Metastatic Castration-Resistant Prostate Cancer (mCRPC) patients who have progressed from earlier stages
- Evidence of inclusion in clinical trials during the study periodTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status |
|---|
Trial Design
REal-world EvideNce study describinG treAtment intensification patterns amonG canadian patiEnts with mHSPC using EHR data from community urology clinics
Trial Type:
Observational
Intervention Type:
N/A
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
5
Primary Outcome
- Treatment intensification in patients with mHSPCThe primary outcome of interest is utilization of treatment intensification in patients with mHSPC, including: Frequencies and percentages of patients in each treatment cohortTimeframe: January 2018 until June 2026
Secondary Outcome
- Demographics and clinical characteristics of patients by treatment cohortDemographic and clinical characteristics of patients who are intensified vs. not intensified by treatment cohortsTimeframe: January 2018 until June 2026
- Physician characteristicsEight urology clinics are being approached for this study, with some being group practices. Up to 30 clinicians are anticipated to provide medical record data for their patientsTimeframe: January 2018 until June 2026
- Reasons for treatment discontinuation and/or changing treatment by treatment cohortReasons for treatment discontinuation and/or changing treatment by treatment cohort, including: o Frequency and percentages of patients discontinuing/changing treatment due to AEs (and treatment-relatedness, if possible) o Frequency and percentages of patients discontinuing/changing treatment due to progression to mCRPC o Frequency and percentages of patients discontinuing treatment due to death o Frequency and percentages of patients discontinuing/changing treatment due to any other reasonTimeframe: January 2018 until June 2026
- Time to treatment discontinuation (TTD)TTD will be measured from start of study treatment (index date 2) until discontinuation of ADT in monotherapy regimens or discontinuation of ARPi in doublet or triplet regimens or discontinuation of docetaxel within < 6 cycles in the docetaxel regimens. Treatment discontinuation will be defined as the last date treatment is givenTimeframe: January 2018 until June 2026
- mCRPC real-world progression free survival (rwPFS)rwPFS will be measured from mHSPC diagnosis (index date 1) until date of progression as documented in physician notes or rising PSA levels (using PCW3 definition) despite castrate testosterone levels, where available, or date of deathTimeframe: January 2018 until June 2026
- Referral patterns for intensification among patients with mHSPCDetermine if the study can identify a pattern in which mHSPC patients can be candidates for intensification therapy, based on the patient data.Timeframe: January 2018 until June 2026
- Docetaxel dosage adjustmentsTimeframe: January 2018 until June 2026
Additional Information
Copyright © Bayer
Powered by
