Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen Receptor Pathway Inhibitors (ARPIs) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Androgen Receptor Pathway Inhibitor Cohort
- description
- Men with metastatic hormone-sensitive prostate cancer receiving androgen receptor pathway inhibitors (abiraterone acetate, apalutamide, enzalutamide, or darolutamide) in combination with standard androgen deprivation therapy. Participants will be assessed at baseline, 3 months, and 6 months for quality of life, cognitive function, fatigue, depression, sleep quality, clinical parameters, and treatment-related adverse events.
- interventionNames
- Drug: Androgen Receptor Pathway Inhibitors (ARPIs)
Primary outcomes (2)
- measure
- Change From Baseline in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Total Score
- timeFrame
- Baseline, 3 months, and 6 months after treatment initiation
- description
- FACT-Cog total score ranges from 0 to 148, with higher scores indicating better cognitive functioning. Both continuous change (follow-up minus baseline) and categorical decline (≥10-point decrease from baseline, indicating clinically meaningful cognitive deterioration) will be assessed.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available