Personalized vs. Fixed-Activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)

Exclusion Criteria

• •1. PSMA-PET "superscan" (i.e. extensive/diffuse PSMA-positive bone involvement);
• •2. Site(s) of disease that are FDG-positive, defined as SUVpeak in at least one lesion that is superior to twice (2x) SUVmean of the liver, and PSMA-negative (as above), within 45 days prior to randomization;
• •3. Prior treatment with more than two lines of chemotherapy for mHSPC and/or mCRPC (adjuvant and neoadjuvant chemotherapy does not count) towards the maximum of two regimens);
• •4. Prior radiopharmaceutical therapy;
• •5. Known CNS metastasis unless they are deemed to be non-progressive, asymptomatic and off corticosteroid therapy for at least four weeks, as per investigator's assessment;
• •6. Active malignancy other than prostate cancer;
• •7. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception;
• •8. Any other condition, diagnosis or finding that may in the investigator's opinion interfere with trial conduct;
• •9. Known hypersensitivity to 177Lu-PSMA-617 or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.