Clinical Trial Search

Primary: Prostate-Specific Antigen (PSA) Response — 14 participants

Primary: Number of Participants With an Immune Response — 2; 4; 4; 3 Participants

Primary: The Number of Subjects With PSMA-positive (Prostate-specific Membrane Antigen) "Dominant" PC Lesion(s) Greater Than 5mm in Diameter, Whose Lesion(s) Have Been…

Primary: Combined pCR or MRD Rate [Part 1] — 12; 12 Participants

Primary: Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) — 3; 2; 6; 3 Participants

Primary: All Cause Mortality — 171; 183 Participants

Primary: Diagnostic Accuracy of PSMA PET — 100; 74 percentage

Primary: Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject — 2.33; 2.03; 1.98; 6.39…

Primary: Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging — 17; 8 number of lesions

Primary: Number of Serious Adverse Events — 0 Participants

Primary: Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT) — 7; 2; 17 Participants

Primary: Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up. — 8 Participants

Primary: Overall Survival — 88.5; 88.1 percentage of participants — p=0.98

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: Change From Baseline in Tissue Gli1 Expression Levels Using qRT-PCR Analysis in Each Group (LDE225 and Observation) — 6; 0 Participants

Primary: Feasibility - Recruitment — 39 Participants

Primary: Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy — .43 proportion of participants

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

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

Primary: Proportion of Patients With Lymph Node Involvement — 4; 28 Participants

Primary: Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response — 12; 14; 6; 3 participants

Primary: Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension — 86; 57 percentage — p=<0.05

Primary: MP-erMRI Classification Sensitivity — 0.875 proportion of true positives

Primary: Number of Patients With Treatment-emergent Adverse Events (TEAEs) — 15; 2; 10; 2 Participants

Primary: Number of Participants With Biochemical Failure at 5 Years — 0; 30 Participants

Primary: Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months — 2.56 percentage of participants — p=<0.0001

Primary: Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology — 75; 71; 84; 54.8 percent

Primary: The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater — 17.7 Percentage of participants

Primary: Comparison of Biomarkers Between Treatment Arms: Percentage Change of Tumor Cells Exhibiting Detectable Staining Within Gleason Grade 3 (GG3) Biomarker Subgroups at…

Primary: Number of Participants With Progression-Free Survival — 66; 84 Participants — p=0.40