In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy

Inclusion Criteria

• •1. Patient has provided written informed consent
• •2. Male aged 18 years or older at screening
• •3. Prostate cancer diagnosed within 12 weeks of commencement of screening
• •4. Histologically or cytologically confirmed adenocarcinoma of the prostate without significant neuroendocrine differentiation or small cell histology OR metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) with a rising serum PSA
• •5. Evidence of metastatic disease on CT and/or bone scan
• •6. PSA \> 10ng/ml prior to commencement of medical ADT or surgical orchidectomy
• •7. Adequate haematological, renal and hepatic functions as defined by:
• •* Absolute neutrophil count \>1.5 x 109/L
• •* Platelet count \>100 x 109/L
• •* Haemoglobin ≥ 90g/L (no red blood cell transfusion in 4 weeks prior to randomisation)
• •* Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)
• •* Total bilirubin \< 1.5 x ULN (unless known or suspected Gilbert syndrome)
• •* Aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 2.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases)
• •8. Have a performance status of 0-2 on the ECOG Performance Scale (see Appendix 1)
• •9. Life expectancy greater than 6 months with treatment
• •10. Assessed by a medical oncologist as suitable for treatment with docetaxel
• •11. Patients must agree to use an adequate method of contraception
• •12. Willing and able to comply with all study requirements, including all treatments and required assessments including follow-up
• •1. Significant PSMA avidity on 68Ga-PSMA PET/CT, defined after central review as a minimum uptake of SUVmax 15 at a site of disease
• •2. High-volume metastatic disease on 68Ga-PSMA PET/CT defined as visceral metastases or ≥ 4 bone metastases with ≥ 1 outside the vertebral column and pelvis (extra-axial skeleton)