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

Study acronym: PRO-MIND
StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Trial completed Show 6 more changesShow less
    • Final enrollment: 230 participants (planned 102)
    • Study completion date changed from estimate of Sep 15, 2026 to Oct 6, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Study description revised
    • Site details revised at 2 of 2 sites
  2. Primary completion date changed from estimate of Mar 1, 2026 to Apr 26, 2026v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2025 to Oct 22, 2025
    • Site details revised at 2 of 2 sites
    v3
  4. Primary endpoints revised (2)
    • Secondary endpoints revised (7)
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07181122
Lead Sponsor Ankara Etlik City Hospital
Collaborators: Gazi University
Conditions
(from sponsor)		 Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Related terms Depression, Fatigue, Prostatic Neoplasms, Sleep Initiation and Maintenance Disorders
Enrollment 230 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov