Actively Recruiting
Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Led by Ankara Etlik City Hospital · Updated on 2026-04-28
102
Participants Needed
2
Research Sites
46 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 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.
CONDITIONS
Official 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 questionnaires (FACT-Cog, FACT-F, PHQ-9, PSQI)
- Written informed consent given
You will not qualify if you...
- Previous systemic treatment for metastatic prostate cancer except up to 3 months of androgen deprivation therapy
- Known severe cognitive impairment preventing questionnaire completion
- Active cancer requiring systemic treatment at the same time
- Unable to follow study procedures or attend follow-up
- Any condition considered by the investigator to interfere with participation or data quality
AI-Screening
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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
CONTACT
E
Enes Yeşilbaş, MD
CONTACT
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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