uso 21207
(PSMAddition): An international Prospective Open-label, Randomized, Phase III Study comparing [177Lu]Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)(CAAA617C12301)
Disease Types: Genitourinary Cancer Research
Eligibility Requirements:
- Metastatic hormone sensitive adenocarcinoma of the prostate
- No: prior systemic cancer therapy for prostate cancer (LHRH agonist/antagonist, CYP 17 inhibitor or ARDT treatment of up to 45 days allowed); previous treatment within 6 months of randomization with Strontium-89, Samarium-153, Rhenium-186 or 188, Radium-223, hemibody irradiation, or previous PSMA targeted radioligand therapy; CNS metastasis that is unstable, symptomatic, or requires corticosteroid treatment; active hepatitis B or C; active clinically significant cardiac disease; unable to maintain raised arm position (if can maintain raised arms with positioning allowed)
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