Clinical Trial Search

Primary: Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation) — 20 Participants

Primary: Prostate Tissue DHT — 0.03; 0.06; 0.03 ng/g

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

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

Primary: Overall Survival — 87; 86 percentage of probability of survival — p=0.70

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

Primary: Change Rate of Prostate-specific Antigen (PSA) < Nadir + 2 ng/mL From First Day of Treatment to 15 Months (Cohort 2) — 100; 100 percentage of participants

Primary: Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate — 22; 3 Participants

Primary: Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy — 26 percentage of…

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

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

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

Primary: Duration of Therapy (DOT) — 18.5 Months

Primary: Percentage of Participants With PSA50 Response — 2 Participants

Primary: Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD) — 30; 16 percentage of participants — p=0.151

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

Primary: Duration of NHT Treatment — 11.9 Months

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

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

Primary: Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year — 54.54 percentage of 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: Combined pCR or MRD Rate [Part 1] — 12; 12 Participants

Primary: Metabolic Syndrome Incidence, Summarized by the Number of Patients With at Least 3 of the 5 Pre-specified Criteria — 5; 3 Participants — p=0.46

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

Primary: Number of Participants With Dose Limiting Toxicities (Phase I and Safety Run-In) — 0; 0 Participants

Primary: Metabolic Syndrome — 0; 0 kilograms