Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04461509 | High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy | PHASE2 | COMPLETED | 62 | — | — | Apr 6, 2021 | Sep 3, 2024 | Mar 25, 2026 | 1 | United States |
The grade of the cancer is assessed by biopsy prior to HIFU. Systematic and targeted prostate biopsies assess presence or absence of cancer in each zone of the prostate, including both systematic and targeted zones. Each zone with cancer is graded using the Gleason score (range 6-10, with higher scores associated with more aggressive disease). The primary outcome is for detection of any additional cancer with advanced imaging techniques of hrMRI or PSMA-PET MRI over standard multiparametric MRI. Any cancer is defined as "Gleason 6 or higher." We also did an exploratory analysis looking at detection of additional cancers with Gleason scores of 7 or higher.
The primary endpoint of the Phase II study is to assess the number of participants with biopsy-proven cancers that mpMRI would have missed compared with hrMRI and/or F18-PSMA PET.
| Arm | Type | Description |
|---|---|---|
| ARM 1 (HIFU) - 18F-PSMA | EXPERIMENTAL | 10 mCi ±20% F18-PSMA injection |
| ARM 2 (RP) - 18F-PSMA | EXPERIMENTAL | 10 mCi ±20% F18-PSMA injection |
| Name | Type | Description |
|---|---|---|
| 18F-PSMA | DRUG | Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer |
Inclusion Criteria: 1. Biopsy consisting of ≥ 10 tissue cores sampled 2. PSA \<20 ng/mL (for HIFU arm only) 3. cT1-cT2c 4. Either overall Gleason score \> 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with \> half of systematic biopsy co...