Quality of life, function, and thinking changes in men with metastatic hormone-sensitive prostate cancer on ARPI plus hormone therapy.
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
This project will see if adding androgen receptor pathway inhibitors to standard hormone therapy changes thinking, fatigue, mood, sleep, or daily function in men with metastatic hormone-sensitive prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 2 sites (Ankara, Yenimahalle and 1 other locations) |
| Trial ID | NCT07181122 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational cohort enrolling 102 men with newly diagnosed metastatic hormone-sensitive prostate cancer at two academic centers in Ankara, Türkiye. Participants starting androgen deprivation therapy plus an androgen receptor pathway inhibitor (abiraterone, apalutamide, enzalutamide, or darolutamide when available) are followed at baseline, 3 months, and 6 months. Patient-reported outcomes use validated Turkish instruments (FACT-Cog, FACT-F, PHQ-9, PSQI) and clinical data including ECOG status, routine labs, and treatment-related adverse events are recorded. The design captures real-world tolerability and short-term changes in cognition, fatigue, mood, sleep, and functional status associated with ARPI use.
Who should consider this trial
Good fit: Men aged 18 or older with histologically confirmed metastatic hormone-sensitive prostate cancer who are starting ADT plus an ARPI and can complete Turkish patient-reported outcome questionnaires and provide informed consent are eligible.
Not a fit: Patients with prior systemic therapy for metastatic prostate cancer (except ≤3 months of ADT), severe cognitive impairment preventing questionnaire completion, concurrent active malignancy requiring systemic treatment, or inability to attend follow-up visits are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If the findings show clear patterns, clinicians and patients could use the information to choose ARPI regimens and tailor supportive care to reduce cognitive, fatigue, or sleep problems.
How similar studies have performed: Prior clinical trials and observational reports have produced mixed evidence—some ARPIs have been linked to cognitive or fatigue effects while agents with lower CNS penetration (e.g., darolutamide) appear to have less impact—so real-world, short-term data in mHSPC remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ankara, Yenimahalle and 1 other locations
- Etlik City Hospital Medical Oncology Department — Ankara, Yenimahalle, Turkey (Türkiye) (Recruiting)
- Gazi University Medical Oncology Department — Ankara, Çankaya, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Galip Can Uyar, MD — Ankara Etlik City Hospital
- Study coordinator: Galip Can Uyar, MD
- Email: g.can_uyar@hotmail.com
- Phone: +905065963812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.