Clinical Trial · NCT07316686

Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma

Overview

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.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Phase

Phase 1

Contacts

Research Center, Assistant (CONTACT)

icesp.pesqclinica@hc.fm.usp.br

+55 11 3893-3566

José Mauricio Mota, MD, PhD (PRINCIPAL_INVESTIGATOR)

Carlos A Buchpiguel, MD, PhD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT07316686

Drug / Compound

PSMA

Isotope(s):

Target(s):

PSMA

FDG

Isotope(s):

Target(s):

Glucose Transport

Ligand Class: Small Molecules

PSMA-I&T

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTAGA

Eligibility

Inclusion

Lesions with uptake at least 1.5 times greater than hepatic background will be considered measurable.
Potassium \> 3.5 mmol/L and \<5.0 mmol/L
Hemoglobin ≥ 12 g/dL
Adequate organ function as defined below:
Creatinine ≤ 1.5 x upper limit of normal
Platelets ≥ 100,000/µL
Presence of metastatic disease on conventional imaging exams (bone scintigraphy and/or CT scan or MRI).
Neutrophils ≥ 1,500/µL
ALT (TGP) ≤ 2.5 x ULN
Radiologic progression defined by the investigator.
AST (TGO) ≤ 2.5 x ULN
PSA ≥2.0 ng/mL with at least two consecutive PSA rises at intervals of at least 1 week.
Performance status per the Eastern Cooperative Oncology Group (ECOG) equal to 0 or 1.
Total Bilirubin ≤ ULN (unless Gilbert's disease)
Patients with castration-resistant disease, defined as testosterone \<50 ng/mL in the context of prior orchiectomy or ongoing androgen deprivation therapy (ADT) with LHRH agonists or antagonists, plus at least one of the criteria below:
Clinical progression defined by the investigator.

Exclusion

Severe urinary incontinence at the investigator's discretion.
Patients with brain metastases visible on 68Ga-PSMA-PET/CT.
18F-FDG-PET/CT will be performed during screening and will be considered exclusionary if there is discordance with the 68Ga-PSMA-PET/CT. Discordance is defined as FDG-hypermetabolic lesions with absent or low PSMA uptake (SUVmax \<10) in more than 50% of measurable metastatic lesions.
Presence of any small-cell or neuroendocrine component of prostate carcinoma.
Prior receipt of chemotherapy or radiopharmaceuticals in the castration-resistant setting.