Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyzna w wieku 18 lat lub starszy
- •Potwierdzony rozpoznanie raka gruczołu krokowego
- •Przerzuty nowotworu widoczne w badaniach obrazowych (skan, tomografia lub rezonans)
- •Rak oporny na leczenie hormonalne (Testosteron poniżej 50 ng/mL)
- •Podwyższony PSA z co najmniej dwoma wzrostami w odstępach tygodniowych
- •Dobry ogólny stan zdrowia (ECOG 0-1)
- •Chęć kontynuacji terapii hormonalnej
- •Prawidłowe wyniki badań krwi i funkcji narządów
✗ Disqualifies
- •Małokomórkowy lub neuroendokrynny typ raka prostaty
- •Wcześniejsze leczenie chemioterapią w stadium oporności hormonalnej
- •Inny aktywny nowotwór wymagający leczenia lub rozpoznany w ciągu ostatnich 5 lat
- •Brak wystarczającego pobrania radioizotopu w zmianach przerzutowych w badaniu PET/CT
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 25, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, Brazil
Trial contact
Research Center, Assistant
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/26/2026.
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