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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

NCT07316686 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Prostate Cancer (Adenocarcinoma)

Interventions

DRUG

Docetaxel 50mg/m2

Intravenous, 50 mg/m², every 3 weeks, up to 10 cycles

DRUG

Docetaxel 60mg/m2

Intravenous, 60 mg/m², every 3 weeks, up to 10 cycles

DRUG

Docetaxel 75 mg/m²

Intravenous, 75 mg/m², every 3 weeks, up to 10 cycles

RADIATION

177Lu-PSMA-I&T

Intravenous administration at a fixed dose of 7.4 GBq every 6 weeks, up to 4 cycles.

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Carlos A Buchpiguel, MD, PhD · Full Professor, Department of Radiology and Oncology

  • José Mauricio Mota, MD, PhD · Medical oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07316686 on ClinicalTrials.gov