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

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)

Trial Details

NCT ID
NCT05893381
Phase
PHASE2
Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • [177Lu]Lu-PSMA I&T
  • Stereotactic Radiotherapy
Locations (sample)
  • Cesena, FC, Italy|44.1391,12.24315
  • Meldola, FC, Italy|44.12775,12.0626

Key Eligibility Criteria

  • 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 al…
  • Patients will be admitted to the therapeutic phase only if diagnostic PET/CT PSMA SUV max is ≥ 3.

For full eligibility, visit ClinicalTrials.gov.

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