Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorAnkara Etlik City Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Male patients aged 18 years and older with histologically or cytologically confirmed metastatic hormone-sensitive prostate cancer, initiating androgen deprivation therapy plus an androgen receptor pathway inhibitor (abiraterone, apalutamide, or enzalutamide) in oncology clinics. Participants will be consecutively enrolled at Ankara Etlik City Hospital and Gazi University Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Androgen Receptor Pathway Inhibitors (ARPIs)
DrugMen 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.
Treatment groups
102 Participants
are divided into 1 treatment groupGroup A: Androgen Receptor Pathway Inhibitor Cohort1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Total Score
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.
Time frame
Baseline, 3 months, and 6 months after treatment initiation2
Change From Baseline in Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Score
FACT-F total score ranges from 0 to 52, with higher scores indicating less fatigue burden (better status). Both continuous change and categorical threshold (FACT-F ≤34 = clinically significant fatigue) will be evaluated.
Time frame
Baseline, 3 months, and 6 months after treatment initiationSecondary outcomes
1
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Depression Score
PHQ-9 total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. Both continuous change and categorical threshold (PHQ-9 ≥10 = moderate-to-severe depression) will be reported.
Time frame
Baseline, 3 months, and 6 months after treatment initiation2
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Both continuous change and categorical threshold (PSQI \>5 = poor sleep quality) will be assessed.
Time frame
Baseline, 3 months, and 6 months after treatment initiation3
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG performance status ranges from 0 (fully active) to 4 (completely disabled), with higher scores indicating worse functional status. Both continuous change and categorical threshold (≥1-point worsening = functional decline) will be evaluated.
Time frame
Baseline, 3 months, and 6 months after treatment initiation4
Change From Baseline in Liver Function Parameters
Change in serum AST (U/L), ALT (U/L), total bilirubin (mg/dL), and alkaline phosphatase (U/L). Higher levels reflect worsening liver function. Continuous values will be reported.
Time frame
Baseline, 3 months, and 6 months after treatment initiationOther outcomes
1
Incidence of Treatment-Related Adverse Events (CTCAE v5.0)
Number and type of adverse events attributed to androgen receptor pathway inhibitor therapy, graded according to CTCAE v5.0 (Grade 1 = mild to Grade 5 = death, with higher grades indicating greater severity).
Time frame
Baseline to 6 months after treatment initiation2
Correlation Between Clinical/Laboratory Parameters and Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Score
Exploratory correlation between clinical/laboratory parameters (e.g., metabolic profile, PSA) and FACT-Cog score change. Both continuous scores (range: 0-148; higher scores = better cognitive function) and categorical decline (≥10-point decrease from baseline = meaningful deterioration) will be analyzed.
Time frame
Baseline to 6 months3
Correlation Between Clinical/Laboratory Parameters and Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Score
Exploratory correlation between clinical/laboratory parameters and FACT-F score change. Both continuous scores (range: 0-52; higher scores = less fatigue burden) and categorical threshold (FACT-F ≤34 = clinically significant fatigue) will be analyzed.
Time frame
Baseline to 6 months4
Correlation Between Clinical/Laboratory Parameters and Patient Health Questionnaire-9 (PHQ-9) Depression Score
Exploratory correlation between clinical/laboratory parameters and PHQ-9 score change. Both continuous scores (range: 0-27; higher scores = worse depression) and categorical threshold (PHQ-9 ≥10 = moderate-to-severe depression) will be analyzed.
Time frame
Baseline to 6 monthsSponsors and contacts
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Ankara Etlik City Hospital
Lead sponsor
Gazi University
Collaborator
Source ClinicalTrials.gov