The primary objective of this study is to evaluate the safety and effectiveness of PFA in patients with localized prostate cancer.
Men ≥ 45 years of age on the day of enrollment with a life expectancy ≥10 years.
Prostate specific antigen (PSA) 4 <10 ng/mL
Gleason score Grade Group 1 or Gleason score ≤ 6
Clinical stage cT1c-T2a
Patients with prostates previously treated with surgery (including minimally invasive), ablation, radiation therapy, chemotherapy, orchiectomy, brachytherapy, cryotherapy, or photodynamic therapy.
Any prior radiation therapy to the pelvis
Any evidence of metastatic disease or nodal disease outside of the prostate.
Presence of implants/stents in the urethra