Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Recruiting · NCT07181122 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ankara Etlik City Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This prospective observational study will evaluate quality of life, functional status, and cognitive outcomes in men with metastatic hormone-sensitive prostate cancer (mHSPC) receiving androgen receptor pathway inhibitors (ARPIs) in addition to standard androgen deprivation therapy. ARPIs in this study include abiraterone acetate, apalutamide, enzalutamide, and darolutamide, depending on local availability. A total of 102 patients will be enrolled from two academic oncology centers in Türkiye. Participants will be assessed at baseline, 3 months, and 6 months using validated Turkish versions of established questionnaires: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Patient Health Questionnaire-9 (PHQ-9), and Pittsburgh Sleep Quality Index (PSQI). Clinical parameters, ECOG performance status, routine laboratory results, and treatment-related adverse events will also be recorded. The primary outcomes are longitudinal changes in FACT-Cog and FACT-F scores. Secondary outcomes include changes in depression, sleep quality, laboratory results, and adverse events. This study will provide real-world evidence on how ARPI therapy affects cognitive health and quality of life in patients with mHSPC.
Who can take part
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
Where it is running
4 locations listed.
- Etlik City Hospital Medical Oncology Department - Ankara, Yenimahalle, Turkey (Türkiye)
- Etlik City Hospital Medical Oncology Department - Ankara, Yenimahalle, Turkey (Türkiye)
- Gazi University Medical Oncology Department - Ankara, Çankaya, Turkey (Türkiye)
- Gazi University Medical Oncology Department - Ankara, Çankaya, Turkey (Türkiye)