Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

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

Treatment groups

70 Participants
are divided into 2 treatment groups