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.
Study Type
OBSERVATIONAL
Enrollment
700
Pentavere
Toronto, Ontario, Canada
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
Time frame: January 2018 until June 2026
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
Time 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
Time 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
Time 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
Time 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
Time 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
Time 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
Time 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
Time 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
Time 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.
Time 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
Time 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
Time 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.
Time 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: * 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
Time 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
Time 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
Time 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.
Time frame: January 2018 until June 2026
Docetaxel dosage adjustments
Time frame: January 2018 until June 2026
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