Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: 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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Metastatic Hormone-sensitive Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Pentavere

Toronto, Ontario, M6G 1A1, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 period

Treatment and study plan

Primary outcomes

  1. Treatment intensification in patients with mHSPC

    Time frame: January 2018 until June 2026

    The primary outcome of interest is utilization of treatment intensification in patients with mHSPC, including: Frequencies and percentages of patients in each treatment cohort

Secondary outcomes

  1. Demographics: age in years

    Time frame: January 2018 until June 2026

    Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiation

  2. Clinical characteristics: date of diagnosis of prostate cancer

    Time frame: January 2018 until June 2026

    Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiation

  3. Clinical characteristics: date of mHSPC diagnosis (as confirmed by radiographic evidence of metastasis with CI or PSMA-PET, and histologically confirmed carcinoma)

    Time frame: January 2018 until June 2026

    Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiation

  4. Clinical characteristics: year of mHSPC diagnosis

    Time frame: January 2018 until June 2026

    Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiation

  5. Clinical characteristics: Eastern Cooperative Oncology Group (ECOG) score

    Time frame: January 2018 until June 2026

    Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiation

  6. Clinical characteristics: Gleason score

    Time frame: January 2018 until June 2026

    Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiation

  7. Clinical characteristics: comorbidities (Charlson Comorbidity Index)

    Time frame: January 2018 until June 2026

    Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiation

  8. Clinical characteristics: disease volume/risk at baseline

    Time frame: January 2018 until June 2026

    Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiation

  9. Clinical characteristics: radiological evidence of metastases (number and site) at time of initial mHSPC diagnosis

    Time frame: January 2018 until June 2026

    Data utilized consists of secondary-use data: all data used was collected as part of routine clinical practice (patients' medical records) prior to study initiation

  10. Physician characteristics: practice size

    Time frame: January 2018 until June 2026

    Physician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the clinicians.

  11. Physician characteristics: years in practice

    Time frame: January 2018 until June 2026

    Physician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the clinicians

  12. Physician characteristics: number of patients seen annually with prostate cancer

    Time frame: January 2018 until June 2026

    Physician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the clinicians

  13. Physician characteristics: treatment areas of expertise

    Time frame: January 2018 until June 2026

    Physician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the clinicians.

  14. Reasons for treatment discontinuation and/or changing treatment by treatment cohort

    Time frame: January 2018 until June 2026

    Reasons for treatment discontinuation and/or changing treatment by treatment cohort, including:

    • Frequency and percentages of patients discontinuing/changing treatment due to AEs (and treatment-relatedness, if possible)
    • Frequency and percentages of patients discontinuing/changing treatment due to progression to mCRPC
    • Frequency and percentages of patients discontinuing treatment due to death
    • Frequency and percentages of patients discontinuing/changing treatment due to any other reason

  15. Time to treatment discontinuation (TTD)

    Time frame: January 2018 until June 2026

    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 given

  16. mCRPC real-world progression free survival (rwPFS)

    Time frame: January 2018 until June 2026

    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 death

  17. Referral patterns for intensification among patients with mHSPC

    Time frame: January 2018 until June 2026

    Determine if the study can identify a pattern in which mHSPC patients can be candidates for intensification therapy, based on the patient data.

  18. Docetaxel dosage adjustments

    Time frame: January 2018 until June 2026

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: RE-ENGAGE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.