Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Prospective Observational Evaluation of Quality of Life, Functional Status, and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer Undergoing Androgen Receptor Pathway Inhibitor Therapy
Sponsor: Ankara Etlik City Hospital + Gazi University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change From Baseline in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Total Score
Time frame: Baseline, 3 months, and 6 months after treatment initiation
Change From Baseline in Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Score
Time frame: Baseline, 3 months, and 6 months after treatment initiation
Secondary Endpoints
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Depression Score
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Histologically or cytologically confirmed metastatic hormone-sensitive prostate cancer (mHSPC) * Planned initiation of androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (abiraterone, apalutamide, or enzalutamide) as part of routine clinical care * Ability to complete patient-reported outcome questionnaires (FACT-Cog, FACT-F, PHQ-9, PSQI) * Written informed consent obtained Exclusion Criteria: * Prior systemic therapy for metastatic prostate cancer (except ≤3 months of ADT) * Known history of severe cognitive impairment that precludes completion of questionnaires * Concurrent active malignancy requiring systemic treatment * Inability to comply with study procedures or follow-up * Any condition judged by the investigator to compromise participation or data integrity
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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