Using Lu-PSMA with SABR for treating oligometastatic prostate cancer
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial
This study is testing whether adding a special targeted therapy called Lu-PSMA to radiation treatment can help people with a few spots of prostate cancer live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Peter MacCallum Cancer Centre, Australia Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 3 sites (St Leonards, New South Wales and 2 other locations) |
| Trial ID | NCT05560659 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of combining stereotactic ablative radiotherapy (SABR) with Lutetium-177 prostate-specific membrane antigen (Lu-PSMA) therapy in improving progression-free survival in patients with oligometastatic prostate cancer. Participants will undergo PSMA PET staging to identify suitable candidates with 1-5 metastatic sites. The study will compare outcomes between those receiving SABR alone and those receiving the combination treatment. The goal is to determine if the addition of Lu-PSMA enhances treatment efficacy over standard SABR alone.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 or older with histologically confirmed prostate adenocarcinoma and 1-5 sites of oligometastatic disease detected via PSMA PET.
Not a fit: Patients with extensive metastatic disease or those who have not undergone prior definitive treatment for the primary cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with oligometastatic prostate cancer.
How similar studies have performed: Previous studies have shown promising results with PSMA-targeted therapies, indicating potential for success with this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 6. 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) 7. Assessed as suitable for SABR by a radiation oncologist 8. Patients must agree to use an adequate method of contraception 9. Have a performance status of 0-1 on the ECOG Performance Scale Exclusion Criteria: 1. 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 2. Any visceral (AJCCC M1c) metastases 3. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression 4. 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 5. 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.
Where this trial is running
St Leonards, New South Wales and 2 other locations
- Royal North Shore — St Leonards, New South Wales, Australia (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
- Sheba Medical Centre — Tel Aviv, Israel (Recruiting)
Study contacts
- Principal investigator: A/Prof. Shankar Siva — Peter MacCallum Cancer Centre, Australia
- Study coordinator: Gaurav Sharma
- Email: Gaurav.Sharma@petermac.org
- Phone: +61 3 8559 6830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.