Does this sound a little strange to anyone except me ?
Patients with PSMA positive scans will be randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus best supportive/best standard of care or to receive best supportive/best standard of care only. Best supportive/best standard of care will be determined by the treating physician/investigator but will exclude investigational agents, cytotoxic chemotherapy, other systemic radioisotopes, and hemi-body radiotherapy. Novel androgen axis drugs [NAADs] (such as abiraterone or enzalutamide) are allowed."
"Lu-PSMA will be provided free of charge in this study to you. The administration of the radionucleotide will be billed to your insurance company. Tests and procedures that are done only for the study will not be billed to you or your insurance company.
You or your insurance company may be billed for all standard medical care given during this research study, including best supportive/best standard-of-care in this study. You may want to talk with your insurance company about its payment policy for standard medical care given during a research study. If your insurance company does not pay, you may be billed for those charges. You will be responsible for any co-pays or deductibles as defined by your insurance for standard-of-care services."
It looks to me like half or more of the costs of this trial will be born by the participant !