Status:
RECRUITING
Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Lead Sponsor:
Ankara Etlik City Hospital
Collaborating Sponsors:
Gazi University
Conditions:
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Eligibility:
MALE
18+ years
Brief 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 recept...
Detailed Description
Metastatic hormone-sensitive prostate cancer (mHSPC) is a disease stage in which systemic treatment strategies significantly affect survival, functional status, and quality of life. The incorporation ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2026
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT07181122
Start Date
October 22 2025
End Date
September 15 2026
Last Update
November 24 2025
Active Locations (2)
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1
Etlik City Hospital Medical Oncology Department
Ankara, Yenimahalle, Turkey (Türkiye), 06270
2
Gazi University Medical Oncology Department
Ankara, Çankaya, Turkey (Türkiye)