Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma
Instituto do Cancer do Estado de São Paulo
18 participants
Jun 16, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
Intravenous, 50 mg/m², every 3 weeks, up to 10 cycles
Intravenous, 60 mg/m², every 3 weeks, up to 10 cycles
Intravenous, 75 mg/m², every 3 weeks, up to 10 cycles
Intravenous administration at a fixed dose of 7.4 GBq every 6 weeks, up to 4 cycles.
Locations(1)
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NCT07316686