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A Phase II Randomized Trial of Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Oligometastatic 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)
Details
| Lead sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 70 |
| Start date | 2023-06-27 |
| Completion | 2032-04 |
Conditions
- Prostate Cancer
Interventions
- [177Lu]Lu-PSMA I&T
- Stereotactic Radiotherapy
Primary outcomes
- 12-month PSA (Prostate-Specific Antigen)-progression-free survival (PSA-PFS) — 12-months
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.
Countries
Italy