Multicenter, open-label, parallel-group, phase II randomized study in patients with oligometastatic prostate cancer with 1-3 asymptomatic metastases of the soft tissue or bone. Eligible patients will be randomized at 1:1 ratio to Stereotactic Radiotherapy followed by Lu-PSMA (arm A) or Stereotactic Radiotherapy (arm B)
Patients with prostate cancer must have 1-3 asymptomatic metastatic lesions that are ≤ 5.0 cm or < 250 cm3 documented at CT/MRI or WBD-MRI.
PSMA-PET/CT positive scan matching with lesions documented on baseline CT/MRI or WBD-MRI.
Patients must have had their primary tumor treated with surgery and/or radiation and previous salvage radiation to the prostate bed or pelvis is allowed.
Patients will be admitted to the therapeutic phase only if diagnostic PET/CT PSMA SUV max is ≥ 3.
No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred more than 6 months prior to enrollment.
PSMA -PET/CT scan more than 3 months.
Spinal cord compression or impending spinal cord compression.
Suspected pulmonary and/or liver metastases.
Parallel
[177Lu]Lu-PSMA I&T
DrugThe radiopharmaceutical 177Lu-PSMA-I\&T will be administered, by slow intravenous injection, in 2 cycles of treatment at 6-8 weekly intervals at a dosage of 7.4 GBq.
Stereotactic Radiotherapy
RadiationAblative stereotactic radiation on the metastatic sites. Delivered in a 1 to 5 fractions regimen, depending on the target size and the surrounding normal tissue constraints,
12-month PSA (Prostate-Specific Antigen)-progression-free survival (PSA-PFS)
To determine the proportion of men with oligometastatic hormone sensitive prostate cancer who have PSA progressed after 12 months from randomization to Stereotactic Radiotherapy and Lu-PSMA versus Radiotherapy alone.
12-month radiographic Progression-free survival (rPFS), Androgen Deprivation Therapy-Free survival (ADT-FS) and Total progression-free survival (PSA-PFS+rPFS)
To assess radiographic progression free survival (PFS) after 12 months, ADT free survival (ADT-FS) and Total progression-free survival (PSA-PFS+rPFS) of Lu-PSMA + Stereotactic Radiotherapy vs Stereotactic Radiotherapy defined as the time interval between the day of randomization and the day of disease progression.
Incidence of Treatment-Emergent Adverse Events [Toxicity]
To describe the toxicity of Lu-PSMA + Stereotactic Radiotherapy vs Stereotactic Radiotherapy for the population enrolled using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Overall survival (OS)
To assess overall survival (OS) defined as the time interval between the day of randomization and death or last contact.
Proportion of subjects with undetectable PSA (<0.2 ng/mL)
To assess proportion of subjects with undetectable PSA (\<0.2 ng/mL) defined as a PSA level ≤0.20 ng/mL as measured during routine follow-up
Click on the lead sponsor to view all of their trials.
