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

NCT07492381 | Not Yet Recruiting

• 1 other identifier: CS-00006
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Primary Effectiveness Endpoint: To quantify the absence of clinically significant cancer (Grade Group ≥2) within the prostate tissue at 6 months post-procedure

  The primary effectiveness endpoint of the study is to quantify the absence of clinically significant cancer (Grade Group ≥2) within the prostate tissue at 6 months post-procedure

  6 months

Study Arms (1)

Single Arm

OTHER

Device: ALPFA BPH PFA System

Interventions

ALPFA BPH PFA System DEVICE

Single arm

Single Arm

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• ALPFA Medical: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Anitha Achyutha

  ALPFA Medical

  STUDY DIRECTOR

Central Study Contacts

Anagha Desai

CONTACT

18578002389; adesai@alpfamed.com

Kothule

CONTACT

adesai@alpfamed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share