do_not_disturb_altRecruitment Complete

Metastatic hormone-sensitive prostate cancer

Bayer Identifier:

22917

ClinicalTrials.gov Identifier:

NCT06874114

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
700
Trial Dates
February 2025 - December 2026
Phase
N/A
Could I Receive a placebo
N/A
Products
Darolutamide+ADT (BAY1841788)
Accepts Healthy Volunteer
N/A

Where to participate

StatusInstitutionLocation
Active, not recruiting
PentavereToronto, M6G 1A1, Canada

Primary Outcome

  • Treatment intensification in patients with mHSPC
    The primary outcome of interest is utilization of treatment intensification in patients with mHSPC, including: Frequencies and percentages of patients in each treatment cohort
    date_rangeTime Frame:
    January 2018 until June 2026

Secondary Outcome

  • Demographics: age in years
    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
    date_rangeTime Frame:
    January 2018 until June 2026
  • Clinical characteristics: date of diagnosis of prostate cancer
    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
    date_rangeTime Frame:
    January 2018 until June 2026
  • Clinical characteristics: date of mHSPC diagnosis (as confirmed by radiographic evidence of metastasis with CI or PSMA-PET, and histologically confirmed carcinoma)
    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
    date_rangeTime Frame:
    January 2018 until June 2026
  • Clinical characteristics: year of mHSPC diagnosis
    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
    date_rangeTime Frame:
    January 2018 until June 2026
  • Clinical characteristics: Eastern Cooperative Oncology Group (ECOG) score
    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
    date_rangeTime Frame:
    January 2018 until June 2026
  • Clinical characteristics: Gleason score
    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
    date_rangeTime Frame:
    January 2018 until June 2026
  • Clinical characteristics: comorbidities (Charlson Comorbidity Index)
    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
    date_rangeTime Frame:
    January 2018 until June 2026
  • Clinical characteristics: disease volume/risk at baseline
    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
    date_rangeTime Frame:
    January 2018 until June 2026
  • Clinical characteristics: radiological evidence of metastases (number and site) at time of initial mHSPC diagnosis
    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
    date_rangeTime Frame:
    January 2018 until June 2026
  • Physician characteristics: practice size
    Physician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the clinicians.
    date_rangeTime Frame:
    January 2018 until June 2026
  • Physician characteristics: years in practice
    Physician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the clinicians
    date_rangeTime Frame:
    January 2018 until June 2026
  • Physician characteristics: number of patients seen annually with prostate cancer
    Physician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the clinicians
    date_rangeTime Frame:
    January 2018 until June 2026
  • Physician characteristics: treatment areas of expertise
    Physician characteristics that are related to treatment intensification. Data was extracted from the EHR where available, and via communication with the clinicians.
    date_rangeTime Frame:
    January 2018 until June 2026
  • Reasons for treatment discontinuation and/or changing treatment by treatment cohort
    Reasons 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 reason
    date_rangeTime Frame:
    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 given
    date_rangeTime Frame:
    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 death
    date_rangeTime Frame:
    January 2018 until June 2026
  • Referral patterns for intensification among patients with mHSPC
    Determine if the study can identify a pattern in which mHSPC patients can be candidates for intensification therapy, based on the patient data.
    date_rangeTime Frame:
    January 2018 until June 2026
  • Docetaxel dosage adjustments
    date_rangeTime Frame:
    January 2018 until June 2026

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
N/A

Additional Information