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

ALPFA Medical Prostate Cancer Pilot Study

The primary objective of this study is to evaluate the safety and effectiveness of PFA in patients with localized 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.

Exclusion Criteria:

1. Patients with prostates previously treated with surgery (including minimally invasive), ablation, radiation therapy, chemotherapy, orchiectomy, brachytherapy, cryotherapy, or photodynamic therapy.
2. Any prior radiation therapy to the pelvis
3. Any evidence of metastatic disease or nodal disease outside of the prostate.
4. Presence of implants/stents in the urethra
5. MRI or anesthesia contraindication, including severe claustrophobia
6. Bladder, genital, or other concomitant cancer within the past 5 years, except basal cell or squamous cell carcinoma of the skin.
7. Chronic or acute prostatitis, neurogenic bladder, active urinary tract infection, sphincter abnormalities, or any other symptom that impacts micturition.
8. Men with renal impairment with a GFR of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
9. 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.
10. Subjects currently participating in other investigational studies unless prior approved by the Sponsor.