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

Inclusion Criteria5

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 Criteria5

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

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.