Clinical Trial Search

Primary: Time to the First On-Study SRE (Non-inferiority) — 521.0; 629.0 Days — p=0.0002

Primary: Bone Metastasis-free Survival — 768.0; 897.00 days — p=0.0284

Primary: Count of Participants Requiring Androgen Deprivation Therapy (ADT) Use at 15 Months — 10 Participants

Primary: Time to First Skeletal Related Event — 31.9; 28.8 months — p=0.385

Primary: Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths — 11; 7; 7; 4 participants

Primary: Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer — 58; 49; 201; 214 participants

Primary: Progression Free Survival (PFS) — 12.9; 18.5 Months

Primary: Time to Development of a Malignant Skeletal-related Events (SRE) — 29.9; 27.4 months — p=0.844

Primary: Biochemical Response Rate — 0 participants

Primary: Symptomatic Skeletal Event Free Survival (SSE-FS) — 22.3; 26.0 Months — p=0.2636

Primary: Percent Change in Bone Mineral Density — 0.1; -2; 0.2; -2.2 Percent Change — p=0.004

Primary: The Number of Subjects Who Had Either an Increase or Decrease on Bone Mineral Density of the Lumbar Spine and Femoral Neck in Men Undergoing Androgen Deprivation Therapy…

Primary: Change in PET Standard Uptake Value SUV Levels Pre-treatment to Post-treatment. — -56 percentage change from baseline

Primary: PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy. — .091 Proportion of participants with response

Primary: Number of Participants With an Event Defining SSE Free Survival - High Dose vs. Standard Dose — 85; 118 Participants

Primary: Median Relapse-Free Survival Time (Biochemical or Clinical) — 45.3 months

Primary: Best Overall PSA Response — 8; 20; 65 percentage of participatns

Primary: Overall Survival (Favorable and Unfavorable ) — 13.9; 36.3 months

Primary: Freedom From Any Bone Fracture (FABF) Rate at Three Years — 98.0; 97.4 percentage of participants — p=0.95

Primary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 — -1; 5.6 Percent Change from Baseline — p=<0.0001

Primary: Fold Change in Serum N-telopeptides From Baseline — 0.85; 1.34 fold change

Primary: Number of Participants With Serious AEs (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs - Treated Participants — 3; 2; 9; 2 participants

Primary: Re-Treatment Rates - Arm 1 (8 Gy x 1) vs. Arm 2 (8 Gy x 2) — 3; 3; 19; 17 Participants — p=0.8325

Primary: Time to Progression (TTP) — 111; 138; 113 Days

Primary: Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment — 28.0; 32.0 percentage of participants — p=0.03

Primary: Rate of Rise of Serum PSA — 0.0825 Nanograms Per Milliliter

Primary: Proportion Responding to Treatment With of the Combination of Ixabepilone and Mitoxantrone Hydrochloride With Prednisone in Hormone Refractory Prostate Cancer Patients…

Primary: Number of Subjects With Dose-Limiting Toxicities - Dose Escalation Part — 0; 0; 0 Participants

Primary: Progression-free Survival — 10.5; 11.8 Months

Primary: The Number of Participants With Improvement, Disease Progression or Stable Disease — 6; 4; 13 Participants