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Procedure

NanoKnife Ablation for Prostate Cancer

N/A
Waitlist Available
Research Sponsored by Angiodynamics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoes transperineal targeted prostate biopsies of lesion, plus 12 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
Must not have
Is unfit for anesthesia or has a contraindication for agents listed for paralysis
Has a history of bladder neck contracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will study whether the NanoKnife System is a safe and effective treatment for localized prostate cancer in intermediate risk subjects.

Who is the study for?
This trial is for men with intermediate-risk, organ-confined prostate cancer. Participants should have a life expectancy of at least 10 years, a PSA ≤ 15 ng/mL or specific PSA density if higher, Gleason score of either 3+4 or 4+3, and no more than 10 mm of cancer in biopsy cores. They must not have had previous major treatments for prostate cancer or certain other medical conditions.Check my eligibility
What is being tested?
The study tests the NanoKnife System's safety and effectiveness as a focal therapy to ablate localized prostate cancer. It involves using the system on patients who meet specific criteria regarding their prostate cancer stage and health status.See study design
What are the potential side effects?
While the side effects are not explicitly listed here, potential risks may include those commonly associated with surgical procedures such as pain, infection at the treatment site, bleeding, urinary issues and possible impacts on sexual function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a specific prostate biopsy procedure targeting a lesion and including additional samples.
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My prostate cancer is confirmed and has not spread beyond the prostate.
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My prostate cancer is in a small area of the biopsy sample.
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I have a tumor visible on MRI that can be treated with IRE.
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My prostate cancer has a Gleason score of 7.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have anesthesia due to health reasons.
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I have had bladder neck contracture.
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I cannot use a catheter because of a narrow urethra.
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I have received treatments for prostate cancer, including surgery or therapy.
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I have had major surgery on my rectum, not including for hemorrhoids.
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I have had surgery or procedures for prostate issues.
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I currently have a urinary tract infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Treatment Morbidity Profile
Treatment procedural and short-term post-treatment safety profile
Secondary outcome measures
Completeness of Ablation
Effectiveness of Therapy
Health-Related Quality of Life
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: NanoKnife ProcedureExperimental Treatment1 Intervention
The NanoKnife procedure will be performed on focal prostate tumors, under ultrasound guidance.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments work through various mechanisms to target and destroy cancer cells. The NanoKnife System, which uses irreversible electroporation, creates permanent pores in cell membranes, leading to cell death without significant thermal damage, preserving surrounding structures. Other common treatments include androgen deprivation therapy (ADT), which reduces androgen levels to inhibit cancer growth; radiation therapy, which damages DNA in cancer cells, leading to cell death; and immunotherapy, which enhances the immune system's ability to target cancer cells. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment based on the cancer's characteristics and the patient's overall health.

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Who is running the clinical trial?

Angiodynamics, Inc.Lead Sponsor
23 Previous Clinical Trials
2,359 Total Patients Enrolled
2 Trials studying Prostate Cancer
137 Patients Enrolled for Prostate Cancer

Media Library

NanoKnife Procedure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01972867 — N/A
Prostate Cancer Research Study Groups: NanoKnife Procedure
~1 spots leftby Jun 2025
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