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

NCT05560659 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-07-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

177Lu-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

Sponsors & Collaborators

  • Varian Medical Systems

    collaborator INDUSTRY

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • A/Prof. Shankar Siva · Peter MacCallum Cancer Centre, Australia

  • Dr Aravind S. Ravi Kumar · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2026-05-31
Completion
2027-05-31

Countries

  • Australia
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560659 on ClinicalTrials.gov