The PROSTACT trial will compare two arms:
Group A: Two single intravenous (IV) injections of 76 mCi each (equivalent to a 45 mCi/m2 dose in a standard 1.7m2 individual) of 177Lu-DOTA- rosopatamab, given 14 days apart, plus best SoC
Group B: Best SoC.
What exactly is best SoC? That's where things get interesting.
"Investigational agents, any form of anti-neoplastic regimens including chemotherapy, platinum based anti-neoplastic drugs, poly adenosine diphosphate ribose polymerase (PARP) inhibitors, other systemic radioisotopes, and hemi-body radiotherapy are excluded from use as best SoC. Use of NAADs, such as abiraterone or enzalutamide, is permitted."
They've ruled out Cabazitaxel from the control arm, this a horrible control arm. Who will want to be in a control that prevents you from taking a lot of life prolonging drugs? There will be a lot of drop outs from the control arm.
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