Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy (POPSTAR II)

NCT 05560659

Brief 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.

Intervention / Treatment

  • Drug: 177Lu-PSMA

Inclusion Criteria:

  1. Male aged 18 years or older at screening
  2. Patient has provided written informed consent
  3. Histologically confirmed prostate adenocarcinoma w
  4. Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery
  5. Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT with a score of 4 or 5 as defined by the E-PSMA criteria
  6. At least one site of disease with SUVmax greater than the SUVmax of liver on PSMA PET (Ga-68 PSMA 11 or F-18 DCFPYL tracers only)
  7. Adequate haematological function as defined by:
    • Absolute neutrophil count (ANC) ≥1.5 x 109/L
    • Platelet count >150x 109/L
    • Haemoglobin ≥100 g/L
    • Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)
  8. Assessed as suitable for SABR by a radiation oncologist
  9. Patients must agree to use an adequate method of contraception
  10. Have a performance status of 0-1 on the ECOG Performance Scale

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