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Procedure

NanoKnife for Prostate Cancer (WIRED Trial)

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a transperineal or transrectal targeted prostate biopsy of MRI-visible lesions, plus 10-14 core systematic biopsy confirming Gleason = 7 in MRI target and absence of Gleason ≥ 7 outside target

Is greater than 50 years of age

Must not have

Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer (Note: subjects with untreated active concomitant cancers are excluded, only subjects deemed to be in remission by their cancer care provider for at least three years are eligible)

Has a history of bladder neck contracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the safety and effectiveness of a treatment called Irreversible Electroporation using NanoKnife technology in patients with intermediate-risk prostate cancer. The main questions it seeks to answer are whether

Who is the study for?

This trial is for individuals with intermediate-risk prostate cancer. It's designed for those who might otherwise undergo conventional therapies that come with significant side effects. Participants will be required to attend follow-up appointments for 12 months after the IRE treatment.

What is being tested?

The trial is testing the safety and effectiveness of a procedure called Irreversible Electroporation (IRE) using NanoKnife technology on prostate tumor cells in patients with intermediate-risk prostate cancer.

What are the potential side effects?

While specific side effects are not detailed, the study aims to identify any major safety concerns or side effects associated with the NanoKnife IRE treatment over a period of 12 months post-procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My biopsy shows a Gleason score of 7 in targeted areas with no higher scores elsewhere.

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I am over 50 years old.

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My prostate cancer is confirmed and has not spread beyond the prostate.

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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 haven't had cancer treatment in the last 3 years, except for prostate or skin cancer.

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I have had a bladder neck contracture.

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I cannot have anesthesia due to health reasons.

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I have had major surgery on my rectum.

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I currently have a urinary tract infection.

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I cannot or do not want to use a catheter.

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I have received treatment for prostate cancer before.

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I have had surgery for a prostate stricture, or I have a urethral stent or prostatic implants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events by type and CTCAE v5.0 severity through 12 months

Rate of negative in-field biopsy at 12 months

Secondary study objectives

Assessment of erectile function after NanoKnife System treatment by comparison of pre- and post-operative IIEF-15 potency scores

Assessment of need for secondary or adjuvant treatment

Assessment of urinary function after NanoKnife System treatment by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite

+3 more

Other study objectives

Collection of data on possible delayed adverse events

Evaluation of longer term effectiveness of focal IRE