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
REal-world EvideNce Study describinG treAtment Intensification Patterns amonG Canadian patiEnts With mHSPC Using EHR Data From Community Urology Clinics
Sponsor: Bayer
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Treatment intensification in patients with mHSPC
Time frame: January 2018 until June 2026
Secondary Endpoints
Demographics: age in years
Clinical characteristics: date of diagnosis of prostate cancer
Clinical characteristics: date of mHSPC diagnosis (as confirmed by radiographic evidence of metastasis with CI or PSMA-PET, and histologically confirmed carcinoma)
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
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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