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

NCT06874114 | Active Not Recruiting

• 1 other identifier: 22917
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Hormone-sensitive Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  January 2018 until June 2026

Secondary Outcomes (18)

• Demographics: age in years

  January 2018 until June 2026

• Clinical characteristics: date of diagnosis of prostate cancer

  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)

  January 2018 until June 2026

• Clinical characteristics: year of mHSPC diagnosis

  January 2018 until June 2026

• Clinical characteristics: Eastern Cooperative Oncology Group (ECOG) score

  January 2018 until June 2026

Study Arms (5)

Cohort A

No Androgen Deprivation Therapy (ADT) nor Androgen Receptor Pathway Inhibitor (ARPi) treatment

Cohort B

Androgen Deprivation Therapy (ADT) Monotherapy: Patients initiating or continuing ADT alone for up to 180 days after Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) diagnosis

Cohort C

Androgen Deprivation Therapy (ADT)+Docetaxel: Patients initiating docetaxel within 180 days of start of ADT after Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) diagnosis

Cohort D

Androgen Deprivation Therapy (ADT)+Androgen Receptor Pathway Inhibitor (ARPi): Patients initiating ARPi within 180 days of start of ADT after mHSPC diagnosis

Cohort E

Androgen Deprivation Therapy (ADT)+Androgen Receptor Pathway Inhibitor (ARPi)+Docetaxel: Patients initiating ARPi and docetaxel within 180 days start of ADT after Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) diagnosis

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Pentavere

Toronto, Ontario, M6G 1A1, Canada

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 13, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)