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
NCT ID: NCT06874114
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
700 participants
OBSERVATIONAL
2025-02-28
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort A
No Androgen Deprivation Therapy (ADT) nor Androgen Receptor Pathway Inhibitor (ARPi) treatment
No interventions assigned to this group
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
No interventions assigned to this group
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
No interventions assigned to this group
Cohort D
Androgen Deprivation Therapy (ADT)+Androgen Receptor Pathway Inhibitor (ARPi): Patients initiating ARPi within 180 days of start of ADT after mHSPC diagnosis
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* At least 6 months follow-up post-diagnosis period, unless the patient died earlier
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Pentavere
Toronto, Ontario, Canada
Countries
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Related Links
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Related Info
Other Identifiers
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22917
Identifier Type: -
Identifier Source: org_study_id
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