Clinical Trial Search

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

Primary: Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA) — 5 Participants

Primary: Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events) — 3 events

Primary: Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA) — 3; 2; 1 Participants

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

Primary: Maximum Tolerated Dose (MTD) — 40; 42.5 gray (Gy)

Primary: Change in Number of Subjects With Adverse Events Will be Collected — 22; 18; 17 Participants

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

Primary: Number of Participants With Dose Limiting Toxicities (Phase I and Safety Run-In) — 0; 0 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: Safety - Evaluate the Frequency of Treatment Related Adverse Events — 30 Participants

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

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

Primary: Biochemical Control Rate — 71; 0 Participants

Primary: Proportion of Patients Showing PSA Nadir — 83 percentage of patients with PSA nadir

Primary: Number of Device and Procedure Related Adverse Events — 24 Number of Adverse Events

Primary: Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology — 38; 50 participants

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

Primary: Number of Participants With One Grade 1 Adverse Event, More Than One Grade 1 Adverse Event, and One Grade 2 Adverse Event — 4; 2; 4 Participants

Primary: Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 — 1 Participants

Primary: The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining

Primary: Prostate Biopsy — 0; 3; 8; 11 participants

Primary: Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity — 0; 0; 0; 1.5 percentage of participants

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

Primary: Change in Plasma IGF-1 From Baseline to Post-Treatment — 19.12; 8.54 ng/mL — p=0.190

Primary: Keyword Description of Each Biopsy Sample — 89 percentage significant cancers detected

Primary: Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) — 12 Participants

Primary: Number of Participants With Negative Biopsies at Month 12 — 28; 17 Participants — p=0.0318

Primary: Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment — 26 Participants

Primary: Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence. — 30 participants