Actively Recruiting
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
Led by Ankara Etlik City Hospital · Updated on 2026-04-28
102
Participants Needed
2
Research Sites
20 weeks
Total Duration
On this page
Sponsors
A
Ankara Etlik City Hospital
Lead Sponsor
G
Gazi University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate quality of life, functional status, and cognitive outcomes in men with metastatic hormone-sensitive prostate cancer (mHSPC) who are receiving androgen receptor pathway inhibitors (ARPIs) alongside standard androgen deprivation therapy. The study focuses on ARPIs such as abiraterone acetate, apalutamide, enzalutamide, and darolutamide, depending on availability, to understand their effects in real-world settings on patients' cognitive health and daily functioning. Participants will be observed without assigned treatment as this is a prospective, multicenter observational study involving 102 men newly diagnosed with mHSPC. They will receive ARPIs in combination with androgen deprivation therapy as part of routine care. Assessments will be conducted at baseline, 3 months, and 6 months to measure changes in cognitive function, fatigue, depression, sleep quality, clinical parameters, and treatment-related adverse events using validated Turkish questionnaires and clinical evaluations. During the study, participants will complete several patient-reported outcome measures including the 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). Researchers will also record clinical data, performance status, lab results, and adverse events over time. The main outcomes measured are changes in cognitive function and fatigue, with secondary outcomes covering depression, sleep quality, ECOG performance status, laboratory tests, and safety profiles. The study will last at least 6 months from treatment initiation.
CONDITIONS
Brief Title
Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed metastatic hormone-sensitive prostate cancer (mHSPC)
- Planned start of androgen deprivation therapy plus an androgen receptor pathway inhibitor (abiraterone, apalutamide, or enzalutamide) as part of routine care
- Ability to complete patient-reported outcome questionnaires (FACT-Cog, FACT-F, PHQ-9, PSQI)
- Provided written informed consent
You will not qualify if you...
- Prior systemic therapy for metastatic prostate cancer except up to 3 months of androgen deprivation therapy
- History of severe cognitive impairment that prevents completing questionnaires
- Having an active cancer requiring systemic treatment other than prostate cancer
- Unable to comply with study procedures or follow-up
- Any condition judged by the investigator to compromise participation or data integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants undergoing routine androgen receptor pathway inhibitor therapy in combination with androgen deprivation therapy are observed for quality of life, cognitive function, fatigue, depression, sleep quality, clinical parameters, and treatment-related adverse events.
Assessments at baseline, 3 months, and 6 months
Trial Site Locations
Total: 2 locations
1
Etlik City Hospital Medical Oncology Department
Ankara, Yenimahalle, Turkey (Türkiye), 06270
Actively Recruiting
2
Gazi University Medical Oncology Department
Ankara, Çankaya, Turkey (Türkiye)
Actively Recruiting
Research Team
G
Galip Can Uyar, MD
E
Enes Yeşilbaş, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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