Metastatic Hormone-sensitive Prostate Cancer
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment intensification in patients with mHSPC | 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
| Measure | Time frame | Description |
|---|---|---|
| Demographics: age in years | 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 |
| Clinical characteristics: date of diagnosis of prostate cancer | 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 |
| Clinical characteristics: date of mHSPC diagnosis (as confirmed by radiographic evidence of metastasis with CI or PSMA-PET, and histologically confirmed carcinoma) | 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 |
| Clinical characteristics: year of mHSPC diagnosis | 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 |
| Clinical characteristics: Eastern Cooperative Oncology Group (ECOG) score | 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 |
| Clinical characteristics: Gleason score | 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 |
| Clinical characteristics: comorbidities (Charlson Comorbidity Index) | 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 |
| Clinical characteristics: disease volume/risk at baseline | 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 |
| Clinical characteristics: radiological evidence of metastases (number and site) at time of initial mHSPC diagnosis | 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 |
| Physician characteristics: practice size | 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. |
| Physician characteristics: years in practice | 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 |
| Physician characteristics: number of patients seen annually with prostate cancer | 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 |
| Physician characteristics: treatment areas of expertise | 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. |
| Reasons for treatment discontinuation and/or changing treatment by treatment cohort | 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 |
| Time to treatment discontinuation (TTD) | 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 |
| mCRPC real-world progression free survival (rwPFS) | 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 |
| Referral patterns for intensification among patients with mHSPC | 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. |
| Docetaxel dosage adjustments | January 2018 until June 2026 | — |
Countries
Canada
Outcome results
None listed