Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Androgen Receptor Pathway Inhibitors (ARPIs)
Treatment groups
102 Participants
are divided into 1 treatment groupSponsors and collaborators
Ankara Etlik City Hospital
Lead sponsor
Gazi University
Collaborator
Source ClinicalTrials.gov