Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue (NCT04972097) | Clinical Trial Compass
CompletedNot Applicable
Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue
United States121 participantsStarted 2022-03-29
Plain-language summary
Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Has a PSA ≤ 15 ng/mL or PSA density \< 0.2 ng/mL2 if PSA is \> 15 ng/mL
. Has Gleason score 3+4 or 4+3
. Has no evidence of extraprostatic extension by mpMRI
. Has no evidence of seminal vesicle invasion by mpMRI, and if suspected, confirmed by biopsy
. Physician is able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation
Exclusion criteria
1. Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject
2. Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With a Negative In-field Biopsy at 12 Months
Timeframe: 12 months
2
Number of Participants With Device-related Adverse Events Through 12 Months