Water Vapor Ablation for Grade Group 3 Prostate Cancer

Inclusion criteria

• . Minimum of 2 targeted cores from a single ROI identified by Central Imaging review, and at least one core confirming GG3 disease on biopsy (lesion may cross the midline); Gleason Grade Group determined by highest Gleason score of the targeted core.
• . GG1 cores from anywhere in the prostate are acceptable.
• . Less than 50% of systematic biopsy cores are positive for GG1 disease. For the \<50% calculation, all positive cores located in the target, are counted as "one core."
• . All positive GG2 or GG3 cores must be located in the lesion, or immediately adjacent to the lesion, as determined by the fusion system's tracking, mapping and imaging documentation features.
• . Additional MRI regions of suspicion that are Central Imaging confirmed PI-RADS ≤3 that are negative on biopsy or GG1 are acceptable.
• . PSMA-PET scan results show no suspicion of metastasis as determined by site read.
• . Per Central Imaging, PSMA-PET scan prostate results are concordant with mpMRI results
• . If PSMA-PET scan indicates an additional area of suspicion from the planned treatment area, a targeted repeat biopsy is required to rule out ≥ GG2.

Exclusion criteria