Clinical Trial Search

Primary: Part A: Number of Participants With Dose-limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants

Primary: The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy — 13; 12 Participants

Primary: Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score at 12 Months — -8.04; -6.60; -9.42 Units on a scale

Primary: Radiographic Progression-Free Survival (PFS) — 33.02; 14.78 Months — p=<0.0001

Primary: Percent Change in Serum Testosterone — 53.46 percentage (%)

Primary: Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab — 4.9; 3.2 months

Primary: Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2) — 24; 8…

Primary: Dihydrotestosterone (DHT) Concentration in Benign Prostate Tissue After a Combination Drug Treatment Based on Genotype Status — 9.066; 5.917; 9.345 nM

Primary: Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) — 17.3; 12.8 percentage of participants — p=0.55

Primary: Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline. — 42.9 Percentage of Participants

Primary: Median Tumor Volume Burden at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) Before and After Surgery — 3.44; 0.62 cc

Primary: Number of Participants With PSA Remission Assessed Using the Prostate Cancer Clinical Trials Working Group (PCWG2) Criteria — 29; 16 Participants

Primary: Percent of Patients With a Prostate-specific Antigen (PSA) Decline of at Least 50% Below Baseline PSA50 Response Rate — 14 Participants

Primary: Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When…

Primary: Number of Subjects With BR Events — 35; 26 Participants

Primary: Radiographic Progression-free Survival (rPFS) — 8.7; 13.8 months — p=<0.00001

Primary: Duration of Therapy (DOT) — 18.5 Months

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

Primary: Antigen Spreading (i.e., a Broader Immune Response) With Greater Associated Response Score Compared to Docetaxel Alone After 19 Weeks — 4.31; 5.63; 4.00 Score on a scale

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

Primary: Number of Participants Progression-free at 18 Months — 0 participants

Primary: Undetectable PSA Rate — 42; 34 participants — p=0.16

Primary: Time to Progression (TTP) — 24.2; 19.1 Months

Primary: Efficacy as Assessed by 2-year PSA Progression-free Survival Rate — 17 Participants

Primary: Number of Patients With Undetectable PSA — 5 Participants

Primary: Duration of NHT Treatment — 11.9 Months

Primary: Number of Participants Progression Free at 1 Year — 13 participants

Primary: Time to Treatment Failure (TTF) — 5.5; 5.7 Months

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: Percentage of Participants With Confirmed Objective Response (Objective Response Rate [ORR]) — 6.8 percentage of participants