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Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma (Lutécio)
This is a Phase I, open-label, single-center study evaluating the safety, tolerability, and recommended Phase II dose of docetaxel when combined with a fixed dose of 177-Lutetium-PSMA-I\&T in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will receive standard androgen deprivation therapy, docetaxel at escalating doses (50 mg/m², 60 mg/m², 75 mg/m² every 3 weeks), and 177Lu-PSMA-I\&T at a fixed dose of 7.4 GBq every 6 weeks (up to 4 cycles). A 3+3 dose escalation design will be employed. Secondary endpoints include safety profile, treatment-limiting toxicities, treatment completion rate, and delayed toxicity. Exploratory endpoints include PSA response, radiographic progression-free survival (rPFS), and PERCIST-based response rate.
Details
| Lead sponsor | Instituto do Cancer do Estado de São Paulo |
|---|---|
| Phase | Phase 1 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 18 |
| Start date | 2026-01 |
| Completion | 2026-12 |
Conditions
- Prostate Cancer (Adenocarcinoma)
Interventions
- Docetaxel 50mg/m2
- Docetaxel 60mg/m2
- Docetaxel 75 mg/m²
- 177Lu-PSMA-I&T
Primary outcomes
- Recommended Phase II Dose (RP2D) of docetaxel in combination with 177Lu-PSMA-I&T — First 3 weeks
Determination of the recommended Phase II dose using a standard 3+3 dose-escalation design.
Countries
Brazil