About this trial
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- [177Lu]Lu-PSMA I&T
- Stereotactic Radiotherapy