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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: ALPFA BPH PFA System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anagha Desai; Phone Number: (669) 257-3263; Email: adesai@alpfamed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm	Device: ALPFA BPH PFA System; Single arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device- or Procedure-related Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher within 90 days of the Ablation Procedure	Proportion of subjects with one or more device- or procedure-related Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher within 90 days of the Ablation Procedure	3 months

Collaborators and Investigators

• Sponsor: ALPFA Medical
• Investigators: Study Director: Anitha Achyutha, ALPFA Medical

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CS-00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pilot study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No