A Prospective, Single-Arm, Pilot Study of the ALPFA BPH PFA System in Men With Low, Intermediate and High-Risk Prostate Cancer

Inclusion Criteria

• •1. Men ≥ 45 years of age on the day of enrollment with a life expectancy ≥10 years.
• •2. Patients meeting prostate cancer risk categorization definitions as follows:
• •1. Low-Risk:
• •* Prostate specific antigen (PSA) 4 \<10 ng/mL
• •* Gleason score Grade Group 1 or Gleason score ≤ 6
• •* Clinical stage cT1c-T2a
• •2. Favorable Intermediate-Risk:
• •* PSA 10-20 ng/mL
• •* Gleason score 3+4 (Grade Group 2)
• •* Clinical stage T2b-T2c
• •* Less than 50% of positive biopsy cores
• •* Only one intermediate-risk factor present
• •3. Unfavorable Intermediate-Risk:
• •* PSA 10-20 ng/mL
• •* Gleason score 4+3 (Grade Group 3)
• •* Clinical stage T2b-T2c
• •* More than 50% of positive biopsy cores
• •4. High-Risk:
• •* Prostate specific antigen (PSA) ≥20 ng/mL
• •* Gleason score 8-10 (Grade Group 4-5)
• •* Clinical stage T3a
• •3. Subjects with unfavorable intermediate or high-risk cancer (inclusion 2c or 2d) must be scheduled to undergo a prostatectomy between 30 days and 6 months post-Ablation Procedure.
• •4. Biopsy confirmed adenocarcinoma of the prostate obtained up to 90 days prior to the Ablation Procedure.
• •5. Willing and able to provide consent and comply with study requirements.