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Brief Title: Investigating the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) on the Treatment of Subjects With CRPC
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
Study ID: NCT02864784
Brief Summary: 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
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Soroka Medical Center, Beer sheva, , Israel