Irreversible Electroporation for Prostate Cancer
(PRESERVE Trial)

Recruiting in Palo Alto (17 mi)

+17 other locations

Overseen ByJonathan Coleman, MD

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Angiodynamics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.

Eligibility Criteria

This trial is for men over 50 with intermediate-risk, organ-confined prostate cancer. They should have a life expectancy of at least 10 years, a PSA ≤ 15 ng/mL or specific PSA density if higher, and Gleason score of either 3+4 or 4+3 without signs of cancer spread on mpMRI. Participants must be able to undergo MRI scans and not have bleeding disorders, active infections, recent other cancers (except certain skin cancers), electronic implants, or previous major prostate treatments.

Inclusion Criteria

I have had detailed prostate biopsies targeting a specific lesion and surrounding areas.

My prostate cancer is confirmed and has not spread beyond the prostate.

My MRI shows no cancer spread to the seminal vesicles, confirmed by biopsy if needed.

I am over 50 years old.

My prostate cancer has a Gleason score of 7.

Exclusion Criteria

I have had major surgery on my rectum.

I cannot have anesthesia or certain paralysis drugs due to health reasons.

I have had surgery or implants for prostate issues.

I have had bladder neck contracture.

I currently have a urinary tract infection.

I have had inflammatory bowel disease in the past 3 years.

I am currently bleeding, on blood thinners, or have a bleeding disorder.

I cannot use a catheter because of a narrow urethra.

Participant Groups

The study tests the NanoKnife System's safety and effectiveness in ablating prostate tissue in patients with intermediate-risk prostate cancer. It involves using Irreversible Electroporation (IRE) as a focal therapy to target and destroy cancer cells while sparing surrounding healthy tissue.

1Treatment groups

Experimental Treatment

Group I: IRE Treatment ArmExperimental Treatment1 Intervention

All patients enrolled in this trial will receive IRE treatment with the NanoKnife System