Castrate Resistant Prostate Cancer With Bone Metastasis Clinical Trial
Official title:
A Prospective, Multicenter, Randomized, Placebo-Controlled, Two-armed, Double-blind Pilot Study to Evaluate the Safety, Tolerability and Efficacy of ACC vs. Placebo for the Treatment of Subjects With Castrate Resistant Prostate Cancer With Bone Metastasis
Studies objectives: To evaluate the safety, tolerability and efficacy of ACC given in combination with ZA or with Denosumab as compared to placebo given with ZA or with Denosumab as outline below: - Safety and Tolerability: - Adverse events (AEs) and serious AEs - Safety laboratory measurements - Hypercalcemic and hypercalciuric episodes - Treatment withdrawal due to AEs and overall Efficacy: - Skeletal Related Events (SREs) - Measurable and evaluable disease progression - Progression Free Survival (PFS) - Pain assessment via the VAS scale
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