Clinical Trial · NCT05560659

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

Overview

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.

Sponsor

Peter MacCallum Cancer Centre

Phase

Phase 2

Contacts

Gaurav Sharma (CONTACT)

gaurav.sharma@petermac.org

+61 3 8559 6830

Dr Aravind S. Ravi Kumar (PRINCIPAL_INVESTIGATOR)

A/Prof. Shankar Siva (PRINCIPAL_INVESTIGATOR)

Annette VanDerHeyden (CONTACT)

annette.vanderheyden@petermac.org

+61488048792

ClinicalTrials.gov

NCT05560659

Drug / Compound

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)
  • Haemoglobin ≥100 g/L
  • Platelet count \>150x 109/L
  • Adequate haematological function as defined by:
  • Assessed as suitable for SABR by a radiation oncologist
  • Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery
  • Patients must agree to use an adequate method of contraception
  • Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT
  • Histologically confirmed prostate adenocarcinoma w
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L
  • Have a performance status of 0-1 on the ECOG Performance Scale

Exclusion

  • Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
  • Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
  • Any visceral (AJCCC M1c) metastases