RecruitingPhase 2NCT05560659

Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy

Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial


Sponsor

Peter MacCallum Cancer Centre, Australia

Enrollment

92 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination approach for men with prostate cancer that has spread to a small number of sites (up to 5 spots in the lymph nodes or bones). It combines a targeted radiation treatment called PSMA-directed therapy with a precise, high-dose radiation technique (stereotactic body radiotherapy, or SBRT) aimed at each of those spots. **You may be eligible if...** - You are a male aged 18 or older - You have been diagnosed with prostate cancer confirmed by biopsy - You previously had definitive treatment (surgery or radiation) for your primary prostate cancer - A special scan (PSMA PET/CT) shows 1 to 5 sites of spread in your lymph nodes or bones - Your blood counts and kidney function are within acceptable ranges - A radiation oncologist has determined you are suitable for the targeted radiation treatment - You are in good general health (able to perform daily activities with little to no restriction) **You may NOT be eligible if...** - You have had prior systemic treatment for metastatic prostate cancer (hormone therapy within the past 6 months also disqualifies you) - The cancer has spread to internal organs (lungs, liver, etc.) - You have spinal cord compression or signs of it - You have another active cancer being 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

DRUG177Lu-PSMA

Lutetium-177 (177Lu)-PSMA is a radiopharmaceutical comprised of a small molecule inhibitor of PSMA that binds with high affinity to PSMA, labelled with 177Lu. 177Lu has favourable characteristics for radionuclide therapy emitting both a short-range (1-2mm) cytotoxic beta-particle, minimising irradiation of non-targeted normal tissues, alongside gamma emission that allows imaging. Numerous retrospective series initially demonstrated high clinical activity and limited normal tissue toxicity using PSMA-617 and PSMA-I\&T, which are the most advanced small molecule inhibitors of PSMA, radiolabelled with 177Lu


Locations(3)

Royal North Shore

St Leonards, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Sheba Medical Centre

Tel Aviv, Israel

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NCT05560659


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