← Back to all trials
Recruiting
NCT07316686
Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma
Conditions: Prostate Cancer (Adenocarcinoma)
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
Sponsor: Instituto do Cancer do Estado de São Paulo
Location: Instituto do Câncer do Estado de São Paulo - ICESP São Paulo
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 Criteria
Inclusion Criteria:
1. Men aged 18 years or older.
2. Histological or cytological diagnosis of prostate adenocarcinoma. The presence of intraductal or cribriform carcinoma will be allowed.
3. Presence of metastatic disease on conventional imaging exams (bone scintigraphy and/or CT scan or MRI).
4. Patients with castration-resistant disease, defined as testosterone \ 3.5 mmol/L and \
Source: ClinicalTrials.gov (NCT07316686). StuddyBuddy aggregates publicly available trial information.
