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Irreversible Electroporation

Irreversible Electroporation for Prostate Cancer (PRESERVE Trial)

N/A
Waitlist Available
Led By Jonathan Coleman, MD
Research Sponsored by Angiodynamics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Transperineal or transrectal targeted prostate biopsies of lesion, plus 10 core systematic biopsies to include adequate sampling of the peripheral zone correlating with an intermediate risk lesion in the area of the MR-visible lesion
Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

PRESERVE Trial Summary

This trial will study whether the NanoKnife System is a safe and effective treatment option for intermediate-risk prostate cancer patients.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, bruising or bleeding due to needle insertion during IRE procedure, infection risk from the procedure itself, possible urinary issues such as difficulty urinating or urinary tract infection following treatment.

PRESERVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had detailed prostate biopsies targeting a specific lesion and surrounding areas.
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My prostate cancer is confirmed and has not spread beyond the prostate.
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My MRI shows no cancer spread to the seminal vesicles, confirmed by biopsy if needed.
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I can attend all required follow-up appointments.
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I have a tumor visible on MRI that can be treated with IRE, and any non-visible tumors meet specific criteria.
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I am over 50 years old.
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My prostate cancer has a Gleason score of 7.

PRESERVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events by type and CTCAE v5.0 severity through 12 months
Rate of negative in-field biopsy at 12 months
Secondary outcome measures
Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI
Assessment of changes in prostate volume
Assessment of erectile function by comparison of pre- and post-operative IIEF-15 potency scores
+5 more

PRESERVE Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irreversible Electroporation
2017
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Angiodynamics, Inc.Lead Sponsor
22 Previous Clinical Trials
2,241 Total Patients Enrolled
2 Trials studying Prostate Cancer
22 Patients Enrolled for Prostate Cancer
Jonathan Coleman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
447 Total Patients Enrolled
Arvin George, MDPrincipal InvestigatorUniversity of Michigan

Media Library

NanoKnife System (Irreversible Electroporation) Clinical Trial Eligibility Overview. Trial Name: NCT04972097 — N/A
Prostate Cancer Research Study Groups: IRE Treatment Arm
Prostate Cancer Clinical Trial 2023: NanoKnife System Highlights & Side Effects. Trial Name: NCT04972097 — N/A
NanoKnife System (Irreversible Electroporation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04972097 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this research initiative being populated with participants?

"To complete the trial, 118 qualified patients must be enrolled. These individuals can receive treatment from multiple sites including University of Rochester in Rochester, New york and Northshore University Healthsystem in Evanston, Illinois."

Answered by AI

Is this study currently enrolling new participants?

"Affirmative. The clinical trial is actively recruiting, with the initial post dated March 29th 2022 and the latest update occurring November 23rd 2022. 118 individuals are required to participate at 11 individual sites."

Answered by AI

What is the goal of this medical experiment?

"This clinical trial aims to observe the incidence of adverse events over a one-year period, with CTCAE v5.0 severity being used as an evaluation metric. Secondary objectives include calculating rate of negative in-field biopsy according to Delphi consensus criterion at 12 months, assessing alterations in prostate volume by comparing pre and post treatment mpMRI scans, and evaluating ablation efficacy through tissue analysis after 3 to 10 days from procedure completion as well as 12 months afterwards."

Answered by AI

How widely is this research endeavor being conducted?

"This clinical trial is available at the University of Rochester in New york, Northshore Univesity Healthsystem in Illinois and Duke University in North carolina. In addition to these sites, 11 more locations are accepting patients for this study."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Fox Chase Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~13 spots leftby Jul 2024