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

ConditionProstate Cancer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age45+

SponsorALPFA Medical

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men ≥ 45 years of age on the day of enrollment with a life expectancy ≥10 years.

Prostate specific antigen (PSA) 4 <10 ng/mL

Gleason score Grade Group 1 or Gleason score ≤ 6

Clinical stage cT1c-T2a

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

ALPFA BPH PFA System
Device
Single arm

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Single ArmOther 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

3 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ALPFA Medical

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: