What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including radiotherapy, radical prostatectomy, and cryoablation, have various side effects. Radiotherapy can lead to bladder and rectal toxicity, as well as sexual dysfunction. Radical prostatectomy may result in urinary incontinence and erectile dysfunction. Cryoablation therapy is associated with complications such as urinary symptoms and sexual dysfunction. The NanoKnife System, which uses irreversible electroporation, is being studied for its feasibility and short-term safety, but detailed side effect profiles are not yet well-established. Overall, sexual dysfunction and urinary issues are common across these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including androgen deprivation therapies (ADT), next-generation androgen receptor inhibitors like enzalutamide and abiraterone, and chemotherapeutic agents such as docetaxel. Additionally, radiopharmaceuticals like radium-223 (Ra-223) have been approved for targeting bone metastases. While the NanoKnife System, which uses irreversible electroporation (IRE) for focal therapy, is still under investigation, these approved treatments offer a range of options for managing prostate cancer at various stages.

What other types of research exist?

Promising novel alternatives to the NanoKnife System for prostate cancer treatment in 2024 include microwave ablation and water vapor ablation. These methods are emerging as effective tissue ablation technologies and may offer comparable outcomes to irreversible electroporation.

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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

No Placebo-Only Group

Summary

This trial is testing the NanoKnife System, which uses electrical pulses to destroy cancer cells, on patients with intermediate risk prostate cancer that hasn't spread beyond the prostate. The goal is to see if this treatment is safe and effective.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment Morbidity Profile

Treatment procedural and short-term post-treatment safety profile

Secondary study objectives

Completeness of Ablation

Effectiveness of Therapy

Health-Related Quality of Life

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 12Eligibility criteria met

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.