RecruitingPhase 2NCT05893381

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

A Phase II Randomized Trial of Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Oligometastatic Prostate Cancer (LUST)


Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Enrollment

70 participants

Start Date

Jun 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding lutetium-PSMA (a targeted radiation treatment delivered through the blood) to stereotactic radiotherapy (precise, high-dose radiation) works better than radiation alone for prostate cancer patients with a small number of metastases (spread to 1–3 spots). **You may be eligible if...** - You have prostate cancer with 1–3 metastatic lesions each no larger than 5 cm - Your PSMA PET scan shows those same spots - Your primary prostate tumor has already been treated with surgery and/or radiation - You have had salvage radiation to the prostate bed or pelvis **You may NOT be eligible if...** - You have more than 3 metastatic lesions - Your PSMA PET scan does not match the spots found on other scans - Your primary tumor has not been treated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[177Lu]Lu-PSMA I&T

The 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.

RADIATIONStereotactic Radiotherapy

Ablative 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,


Locations(2)

UO Medicina Nucleare, AUSL della Romagna

Cesena, FC, Italy

UO Medicina Nucleare, IRCCS IRST

Meldola, FC, Italy

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NCT05893381


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