Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer

NCT07181122 | Recruiting

• 1 other identifier: AEŞH-EK-2025-0132
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 2

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 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

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Keywords

Prostate cancer; mHSPC; Androgen receptor pathway inhibitors; Abiraterone; Apalutamide; Enzalutamide; Darolutamide; Quality of life; Cognitive function; Fatigue; Depression; Sleep quality; Patient-reported outcomes

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 3 months, and 6 months after treatment initiation

• 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.

  Baseline, 3 months, and 6 months after treatment initiation

Secondary Outcomes (7)

• Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Depression Score

  Baseline, 3 months, and 6 months after treatment initiation

• Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score

  Baseline, 3 months, and 6 months after treatment initiation

• Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

  Baseline, 3 months, and 6 months after treatment initiation

• Change From Baseline in Liver Function Parameters

  Baseline, 3 months, and 6 months after treatment initiation

• Change From Baseline in Renal Function Parameters

  Baseline, 3 months, and 6 months after treatment initiation

Other Outcomes (5)

• Incidence of Treatment-Related Adverse Events (CTCAE v5.0)

  Baseline to 6 months after treatment initiation

• Correlation Between Clinical/Laboratory Parameters and Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Score

  Baseline to 6 months

• Correlation Between Clinical/Laboratory Parameters and Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Score

  Baseline to 6 months

Study Arms (1)

Androgen Receptor Pathway Inhibitor Cohort

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.

Drug: Androgen Receptor Pathway Inhibitors (ARPIs)

Interventions

Androgen Receptor Pathway Inhibitors (ARPIs) DRUG

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.

Also known as: Abiraterone acetate, Apalutamide, Enzalutamide, Darolutamide

Androgen Receptor Pathway Inhibitor Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only biologically male participants are eligible, as prostate cancer occurs exclusively in males. Self-identified gender does not alter eligibility since inclusion is based on biological sex.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead
• Gazi University: collaborator

Study Sites (2)

Etlik City Hospital Medical Oncology Department

Ankara, Yenimahalle, 06270, Turkey (Türkiye)

RECRUITING

Gazi University Medical Oncology Department

Ankara, Çankaya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Fatigue; Depression; Sleep Initiation and Maintenance Disorders

Interventions

Abiraterone Acetate; apalutamide; enzalutamide; darolutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Galip Can Uyar, MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Galip Can Uyar, MD

CONTACT

+905065963812; g.can_uyar@hotmail.com

Enes Yeşilbaş, MD

CONTACT

+905321795590; yesilbas126@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncology Specialist

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: October 22, 2025
• Primary Completion: April 26, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)