Not Yet RecruitingNot Applicable

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

50 participantsStarted 2026-04

Plain-language summary

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

Age range45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. Favorable Intermediate-Risk:
✓. Unfavorable Intermediate-Risk:
✓. High-Risk:
✓. 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.

✕. 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).

Device- or Procedure-related Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher within 90 days of the Ablation Procedure

Timeframe: 3 months

NCT IDNCT07492381

SponsorALPFA Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Anagha Desai

Who can participate

Age range45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. Favorable Intermediate-Risk:
✓. Unfavorable Intermediate-Risk:
✓. High-Risk:
✓. 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.

✕. 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).