Clinical trial 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
Official title: REal-world EvideNce Study describinG treAtment Intensification Patterns amonG Canadian patiEnts With mHSPC Using EHR Data From Community Urology Clinics
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Hormone-sensitive Prostate Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-03-13
Enrollment: 700
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include patients from 8 community urology clinics across two Canadian provinces. According to the Canadian Urological Association (CUA), community urologists are defined as non-academic institutions with considerably less access to residents, allied professional support, new technology, research funding, and/or continuous peer-review. Their referral base is primarily family physicians, and their teaching responsibilities include primarily family physicians and nurses.

The 8 community urology clinics will be selected purposefully based on the specific data needs to address the study objectives, taking into consideration factors such as clinic size, and where possible, uptake of treatment intensification to increase the generalizability of the findings.

However, it is acknowledged that this is a convenience sample, and may not accurately represent the wider mHSPC Canadian population.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment intensification in patients with mHSPC
timeFrame: January 2018 until June 2026
Secondary outcomes:
measure: Demographics: age in years
timeFrame: January 2018 until June 2026
measure: Clinical characteristics: date of diagnosis of prostate cancer
timeFrame: January 2018 until June 2026
measure: Clinical characteristics: date of mHSPC diagnosis (as confirmed by radiographic evidence of metastasis with CI or PSMA-PET, and histologically confirmed carcinoma)
timeFrame: January 2018 until June 2026
measure: Clinical characteristics: year of mHSPC diagnosis
timeFrame: January 2018 until June 2026
measure: Clinical characteristics: Eastern Cooperative Oncology Group (ECOG) score
timeFrame: January 2018 until June 2026
measure: Clinical characteristics: Gleason score
timeFrame: January 2018 until June 2026
measure: Clinical characteristics: comorbidities (Charlson Comorbidity Index)
timeFrame: January 2018 until June 2026
measure: Clinical characteristics: disease volume/risk at baseline
timeFrame: January 2018 until June 2026
measure: Clinical characteristics: radiological evidence of metastases (number and site) at time of initial mHSPC diagnosis
timeFrame: January 2018 until June 2026
measure: Physician characteristics: practice size
timeFrame: January 2018 until June 2026
measure: Physician characteristics: years in practice
timeFrame: January 2018 until June 2026
measure: Physician characteristics: number of patients seen annually with prostate cancer
timeFrame: January 2018 until June 2026
measure: Physician characteristics: treatment areas of expertise
timeFrame: January 2018 until June 2026
measure: Reasons for treatment discontinuation and/or changing treatment by treatment cohort
timeFrame: January 2018 until June 2026
measure: Time to treatment discontinuation (TTD)
timeFrame: January 2018 until June 2026
measure: mCRPC real-world progression free survival (rwPFS)
timeFrame: January 2018 until June 2026
measure: Referral patterns for intensification among patients with mHSPC
timeFrame: January 2018 until June 2026
measure: Docetaxel dosage adjustments
timeFrame: January 2018 until June 2026
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Pentavere
state: Ontario
Study officials:
References: