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

Inclusion criteria

• Men ≥ 45 years of age on the day of enrollment with a life expectancy ≥10 years.
• Patients meeting prostate cancer risk categorization definitions as follows:

• Low-Risk:

• Prostate specific antigen (PSA) 4 <10 ng/mL
• Gleason score Grade Group 1 or Gleason score ≤ 6
• Clinical stage cT1c-T2a
• 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
• 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
• High-Risk:

• Prostate specific antigen (PSA) ≥20 ng/mL
• Gleason score 8-10 (Grade Group 4-5)
• Clinical stage T3a
• 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.
• Biopsy confirmed adenocarcinoma of the prostate obtained up to 90 days prior to the Ablation Procedure.
• Willing and able to provide consent and comply with study requirements.

Exclusion criteria

• 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
• MRI or anesthesia contraindication, including severe claustrophobia
• Bladder, genital, or other concomitant cancer within the past 5 years, except basal cell or squamous cell carcinoma of the skin.
• Chronic or acute prostatitis, neurogenic bladder, active urinary tract infection, sphincter abnormalities, or any other symptom that impacts micturition.
• Men with renal impairment with a GFR of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
• Any other condition, illness, or surgery, that in the opinion of the Investigator might confound the results of the study or pose additional risks to the patient.
• Subjects currently participating in other investigational studies unless prior approved by the Sponsor.