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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
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.

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.

Find a Location

Who is running the clinical trial?

Angiodynamics, Inc.Lead Sponsor
22 Previous Clinical Trials
2,356 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

Frequently Asked Questions

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

In what ways is this experiment looking to advance healthcare?

"According to Angiodynamics, Inc., the principal outcome that will be assessed over a 6-month period is 'Treatment Morbidity Profile.' In addition, other secondary goals include evaluating Health-Related Quality of Life via patient questionnaires, Prostate Specific Antigen Kinetics (PSA) in relation to NanoKnife treatment parameters and Completeness of Ablation determined through histological evaluation. Imaging techniques are also employed to measure necrosis or residual tissue post-treatment; along with biochemical and clinical progression rates used to determine therapy effectiveness."

Answered by AI

Is there still room for participants within this clinical trial?

"The clinical trial details on clinicaltrials.gov imply that recruitment has ceased; the study was initially posted in May 2021 and last updated in June 2022. Nevertheless, there are still over 1,300 other trials actively recruiting patients across various locations."

Answered by AI

Who else is applying?

What state do they live in?
Hawaii
New York
Florida
Other
How old are they?
18 - 65
65+
What site did they apply to?
Rush University Medical Center
Baptist Hospital of Miami
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Interested in nanoknife surgery.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Mayo Clinic: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study of NanoKnife for Ablation of Prostate Cancer in Intermediate Risk Patients
2021. "Study of NanoKnife for Ablation of Prostate Cancer in Intermediate Risk Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01972867.
All > Minnesota > Paid Studies Florida
~2 spots leftby Apr 2025
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