Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)PRO-MINDNCT07181122
Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer
An observational study of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- What is being tested?
- Androgen Receptor Pathway Inhibitors (ARPIs)
- How many people
- 230 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 22 Oct 2025to 6 Oct 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Etlik City Hospital Medical Oncology Department
Ankara, Yenimahalle, 06270
Gazi University Medical Oncology Department
Ankara, Çankaya
About this study
Official title: 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 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.
Read the 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 of androgen receptor pathway inhibitors (ARPIs) into clinical practice has improved oncological outcomes, yet their influence on cognitive function, fatigue, mood, and sleep requires further real-world investigation.
In this study, the term androgen receptor pathway inhibitors (ARPIs) refer to abiraterone acetate, apalutamide, enzalutamide, and darolutamide. While abiraterone, apalutamide, and enzalutamide are widely used in routine practice in Türkiye, darolutamide may also be included when accessible. All patients will receive ARPIs in combination with standard androgen deprivation therapy (ADT).
This prospective, multicenter, observational cohort study will enroll 102 patients with newly diagnosed mHSPC at Ankara Etlik City Hospital and Gazi University. Assessments will take place at baseline, 3 months, and 6 months.
Validated Turkish patient-reported outcome instruments will be applied:
FACT-Cog: score range 0-148; higher scores = better cognitive functioning.
FACT-F: score range 0-52; higher scores = less fatigue.
PHQ-9: score range 0-27; cut-offs: 5 (mild), 10 (moderate), 15 (moderately severe), 20+ (severe depression).
PSQI: score range 0-21; global score >5 indicates poor sleep quality.
Additional measures will include ECOG performance status (0-5; higher = worse functioning), demographic and clinical characteristics, comorbidities, and routine laboratory tests. Treatment-related adverse events will be recorded according to CTCAE criteria.
The primary outcomes are longitudinal changes in FACT-Cog and FACT-F scores between baseline, 3 months, and 6 months. Secondary outcomes include changes in PHQ-9 and PSQI scores, ECOG performance status, and laboratory results, as well as adverse event profiles. Exploratory analyses will assess the relationship between clinical or laboratory variables and patient-reported outcomes.
Statistical analyses will include descriptive statistics, group comparisons, and repeated-measures modeling. Multivariable regression will be applied to identify predictors of impaired cognitive or functional outcomes.
By incorporating validated Turkish instruments and explicitly defining ARPI agents, this study aims to generate robust real-world evidence on the cognitive, functional, and quality-of-life effects of ARPI therapy in mHSPC. The findings are expected to guide supportive care strategies and optimize treatment decision-making.
- Being tested
- Androgen Receptor Pathway Inhibitors (ARPIs)
- Keywords
- Prostate cancer, mHSPC, Androgen receptor pathway inhibitors, Abiraterone, Apalutamide, Enzalutamide, Darolutamide, Quality of life, Cognitive function, Fatigue, Depression, Sleep quality, Patient-reported outcomes
- Medical subject headings
- Prostatic Neoplasms, Fatigue, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen Receptor Pathway Inhibitors (ARPIs)Drug
Also called Abiraterone acetate, Apalutamide, Enzalutamide, Darolutamide
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Androgen Receptor Pathway Inhibitors (ARPIs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 months, and 6 months after treatment initiation
Secondary outcomes (7)
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.
Measured: Baseline, 3 months, and 6 months after treatment initiation
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.
Measured: Baseline, 3 months, and 6 months after treatment initiation
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.
Measured: Baseline, 3 months, and 6 months after treatment initiation
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.
Measured: Baseline, 3 months, and 6 months after treatment initiation
Change From Baseline in Renal Function Parameters
Change in serum creatinine (mg/dL) and estimated glomerular filtration rate (eGFR, mL/min/1.73 m²). Higher creatinine and lower eGFR reflect worse renal function. Continuous values will be reported.
Measured: Baseline, 3 months, and 6 months after treatment initiation
Change From Baseline in Electrolyte Levels
Change in serum sodium, potassium, calcium, and other routine electrolytes (mmol/L). Both increases and decreases outside the normal reference range will be noted. Continuous values will be reported.
Measured: Baseline, 3 months, and 6 months after treatment initiation
Change From Baseline in Complete Blood Count (CBC)
Change in hemoglobin (g/dL), white blood cell count, neutrophils, lymphocytes, and platelet count (×10⁹/L). Both continuous changes and categorical thresholds (e.g., anemia = hemoglobin <12 g/dL) will be reported.
Measured: Baseline, 3 months, and 6 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start22 Oct 2025
- Primary completion26 Apr 2026
- Study completion6 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
- Investigators
- Galip Can Uyar, MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181122
- Sponsor's protocol ID
- AEŞH-EK-2025-0132
- Other IDs
- AEŞH-EK-2025-0132
- Acronym
- PRO-MIND
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No