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Irreversible Electroporation for Prostate Cancer (PRESERVE Trial)
PRESERVE Trial Summary
This trial will study whether the NanoKnife System is a safe and effective treatment option for intermediate-risk prostate cancer patients.
PRESERVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPRESERVE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PRESERVE Trial Design
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Who is running the clinical trial?
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- I have had major surgery on my rectum.I have had detailed prostate biopsies targeting a specific lesion and surrounding areas.You are expected to live for at least 10 more years.I have received treatments for prostate cancer, including surgery, chemotherapy, hormonal therapy within the last three months, radiotherapy, or biologic therapy.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 haven't had cancer treatment in the last 3 years, except for prostate or skin cancer.My prostate cancer is confirmed and has not spread beyond the prostate.I am interested in preserving my ability to have children.I have had inflammatory bowel disease in the past 3 years.My MRI shows no cancer spread to the seminal vesicles, confirmed by biopsy if needed.I am currently bleeding, on blood thinners, or have a bleeding disorder.I can attend all required follow-up appointments.You have a serious illness that limits your ability to function normally.I cannot use a catheter because of a narrow urethra.I have a tumor visible on MRI that can be treated with IRE, and any non-visible tumors meet specific criteria.I am over 50 years old.You are allergic to pancuronium bromide, atricurium, or cisatricurium.You are expected to live for at least 10 more years.My prostate cancer has a Gleason score of 7.
- Group 1: IRE Treatment Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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