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NCT07181122: PRO-MIND
Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer
trial testing Androgen Receptor Pathway Inhibitors (ARPIs) in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) in 102 participants. Currently enrolling.
1 March 2026
Quick facts
| Lead sponsor | Ankara Etlik City Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 102 |
| Start date | 22 October 2025 |
| Primary completion | 1 March 2026 |
| Estimated completion | 15 September 2026 |
| Sites | 2 locations across Turkey (Türkiye) |
Drugs / interventions tested
- Androgen Receptor Pathway Inhibitors (ARPIs) — full drug profile →
Conditions studied
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) — all drugs for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) →
Sponsor
Ankara Etlik City Hospital
Who can join
18 and older, male only, with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07181122
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Androgen Receptor Pathway Inhibitors (ARPIs)
Trials testing the same drug.
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other recruiting trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Currently open trials in the same condition.
- NCT07190300 — TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulm · Phase 1, PHASE2 · recruiting
- NCT06019676 — Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients · active not recruiting
- NCT05956639 — Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC · Phase 3 · recruiting
- NCT05649943 — Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment · NA · recruiting
- NCT05683964 — Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression · EARLY_PHASE1 · active not recruiting
Other Ankara Etlik City Hospital trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07181122 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ankara Etlik City Hospital
- Last refreshed: 24 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07181122.
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