Lu-PSMA with radiotherapy for limited spread of prostate cancer
Tests radiotherapy alone versus radiotherapy plus Lu-PSMA in men with prostate cancer.
Plain-language title generated from the registry record
Registry title: Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy
Key facts
- Where
- Melbourne and St Leonards, AustraliaSee the 3 sites
- Phase
- Phase 2
Where in Australia
- Icon Cancer CentreMelbourne, AustraliaTaking people
- Peter MacCallum Cancer CentreMelbourne, AustraliaTaking people
- Royal North ShoreSt Leonards, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peter MacCallum Cancer Centre, Australia
- Trial code
- NCT05560659
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial
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.
Inclusion: Male aged 18 years or older at screening; Patient has provided written informed consent; Histologically confirmed prostate adenocarcinoma w; Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery; Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT; 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); Assessed as suitable for SABR by a radiation oncologist; Patients must agree to use an adequate method of contraception; Have a performance status of 0-1 on the ECOG Performance Scale.
Exclusion: Has a known additional malignancy that is progressing or required active treatment in the last 2 years Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma in situ such as breast cancer in situ that has undergone potentially curative therapy are not excluded; 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; Any visceral (AJCCC M1c) metastases; Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression.