RecruitingNCT07181122

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

Enrollment

102 participants

Start Date

Oct 22, 2025

Study Type

OBSERVATIONAL

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Summary

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking quality of life, thinking and memory (cognitive function), fatigue, mood, and sleep in men who are newly starting hormone therapy for prostate cancer that has spread. It aims to understand how these treatments affect daily wellbeing over time. **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic hormone-sensitive prostate cancer (cancer that has spread and not yet become hormone-resistant) - You are about to start androgen deprivation therapy (ADT) combined with a newer hormone-blocking medication like abiraterone, apalutamide, or enzalutamide - You are able to complete questionnaires about your health and wellbeing **You may NOT be eligible if...** - You have had prior systemic therapy for metastatic prostate cancer (except up to 3 months of ADT) - You have a history of severe cognitive impairment - You have another active cancer requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAndrogen Receptor Pathway Inhibitors (ARPIs)

Men with metastatic hormone-sensitive prostate cancer will receive androgen receptor pathway inhibitors (abiraterone acetate, apalutamide, enzalutamide, or darolutamide) in addition to standard androgen deprivation therapy. The choice of ARPI will be determined by routine clinical practice. The study does not assign treatments; it observes patient outcomes under real-world conditions.