Prostate CancerPRESERVENCT04972097
Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue
A study testing Irreversible Electroporation in people with Prostate Cancer, run by Angiodynamics, Inc. at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Irreversible Electroporation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 17 sitesUnited States
- Study dates
- 29 Mar 2022to 14 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is greater than 50 years of age
- Has at least a 10-year life expectancy
- Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c
- 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
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- 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
- Transperineal or transrectal targeted prostate biopsies of lesion, plus 10 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
- A visible lesion on mpMRI that is accessible to Irreversible Electroporation (IRE) treatment (Note: A non-MRI visible lesion detected via systematic standard biopsy will not be considered an exclusion criterion provided the non-MRI visible lesion is singularly located in the contralateral hemisphere of the prostate; is Gleason 6; and comprises no more than 6 mm linear extent of prostate-bearing tissue in a single core on standard biopsy)
- Has signed a written informed consent and in the judgment of the physician, the study is in the best interest of the subject
- Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
Who cannot join
- Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
- Is unfit for anesthesia or has a contraindication for agents listed for paralysis
- Has an active urinary tract infection (UTI)
- Has a history of bladder neck contracture
- Is interested in future fertility
- Has a history (within 3 years) of inflammatory bowel disease
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- Has a concurrent major debilitating illness
- Had active treatment for a malignancy within 3 years, including malignant melanoma, except for prostate cancer or other types of skin cancer
- Has any active implanted electronic device (e.g., pacemaker)
- Is unable to catheterize due to a urethral stricture disease
- Has had prior or current prostate cancer therapies:
- Biologic therapy for prostate cancer
- Chemotherapy for prostate cancer
- Hormonal therapy for prostate cancer within three months of procedure
- Radiotherapy for prostate cancer
- Surgery for prostate cancer
- Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
- Has had prior major rectal surgery (except hemorrhoids)
- Is unfit for pelvic MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute significant image artifacts, allergy or contraindication to gadolinium (to enhance MRI))
- Is actively bleeding, is anticoagulated or on blood thinning medications, or has a bleeding disorder
- Is a member of a vulnerable population such as prisoners, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons
- In the opinion of the treating physician, has a contraindication listed in the current NanoKnife System User Manual (section 2.3)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
VA Ann Arbor Health Care
Ann Arbor, Michigan, 48105
University of Colorado
Aurora, Colorado, 80045
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45221
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
Northshore University Healthsystem
Evanston, Illinois, 60201
University of Florida Health
Gainesville, Florida, 32610
Duly Health and Care
Lisle, Illinois, 60532
NYU Langone Health
New York, New York, 10017
Northwell Health
New York, New York, 10022
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medicine
New York, New York, 10065
University of California Irvine
Orange, California, 92868
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic
Rochester, Minnesota, 55905
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population
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.
- Conditions
- Prostate Cancer
- Being tested
- Irreversible Electroporation
- Keywords
- Prostate Cancer, Prostate Tissue, NanoKnife System, Focal Therapy, Intermediate-Risk, Irreversible Electroporation (IRE)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible ElectroporationDevice
Also called The NanoKnife System
IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
| Study group | Role | What they receive |
|---|---|---|
| IRE Treatment Arm | Experimental | All patients enrolled in this trial will receive IRE treatment with the NanoKnife System Receives: Device: Irreversible Electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Negative In-field Biopsy at 12 Months
Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months
Measured: 12 months
Number of Participants With Device-related Adverse Events Through 12 Months
Number of participants who experienced any adverse event related to the study device during the study
Measured: 12 months
Secondary outcomes (9)
Number of Participants With a Negative In-field Biopsy at 12 Months as Defined by the Delphi Consensus Criterion
Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months, as defined by the Delphi consensus criterion of absence of clinically significant disease (where ≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is considered insignificant)
Measured: 12 months
Assessment of Urinary Function by Comparison of Pre- and Post-operative UCLA Expanded Prostate Cancer Index Composite
Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite (UCLA-EPIC) Urinary Domain (range from 0-100 with higher scores representing better quality of life) and International Prostate Symptom Scores (IPSS) (range from 0 to 35 (asymptomatic to very symptomatic)) and IPSS Quality of Life (IPSS-QoL) scores (range from zero (0) indicating Delighted to six (6) indicating Terrible), change from Baseline to 12 Months
Measured: 12 months
Assessment of Erectile Function by Comparison of Pre- and Post-operative IIEF-15 Potency Scores
Assessment of erectile function by comparison of pre- and post-operative 15-Item International Index of Erectile Function (IIEF-15) potency scores, change from Baseline to 12 Months (range 0 - 75, higher scores indicate less dysfunction/higher satisfaction)
Measured: 12 months
Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics
Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, including PSA nadir
Measured: 12 months
Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics, Percent Change From Baseline
Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics, percent change from baseline
Measured: 12 months
Assessment of Changes in Prostate Volume
Assessment of percent change in prostate volume by comparison of pre-treatment and 12-month prostate volume measured via mpMRI.
Measured: 12 months
Assessment of Ablation Effectiveness by Evaluation of Prostate Tissue by mpMRI
Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI at 12 months post-treatment, using the PI-RADS scoring system, a 1-to-5 scale used on prostate MRI to indicate the likelihood of clinically significant prostate cancer, with higher scores suggesting greater suspicion of cancer.
Measured: 12 months
Assessment of Need for Secondary or Adjuvant Treatment
Assessment of need for secondary or adjuvant treatment following treatment with the NanoKnife System.
Measured: 12 months
Evaluation of Subject Reported Pre- and Post-operative Quality of Life, Change From Baseline to 12 Months
Evaluation of subject reported pre- and post-operative Quality of Life (QoL) using the 5-dimension scale EuroQoL (EQ-5D®) EQ VAS. Scale ranges from minimum of 0 (worse) to 100 (better/best).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start29 Mar 2022
- Primary completion14 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Angiodynamics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Coleman, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterArvin George, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972097
- Sponsor's protocol ID
- 2021-ONC-01
- Acronym
- PRESERVE
- Status last verified
- May 2026
- First submitted
- 2 Jul 2021
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population
- ClinicalTrials.gov ID
- NCT04972097
- Acronym / sponsor ID
- PRESERVE / 2021-ONC-01
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Prostate Tissue, NanoKnife System, Focal Therapy, Intermediate-Risk, Irreversible Electroporation (IRE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Angiodynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 2 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRE Treatment Arm | Experimental | Device: Irreversible ElectroporationAll patients enrolled in this trial will receive IRE treatment with the NanoKnife System |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Is greater than 50 years of age
- Has at least a 10-year life expectancy
- Has histologically confirmed organ-confined prostate cancer, clinical stage ≤ T2c
- 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
Key exclusion criteria (22 listed)
- Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
- Is unfit for anesthesia or has a contraindication for agents listed for paralysis
- Has an active urinary tract infection (UTI)
- Has a history of bladder neck contracture
- Is interested in future fertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irreversible ElectroporationAlso: The NanoKnife SystemIRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes. | Device | IRE Treatment Arm |
Primary outcome
Number of Participants With a Negative In-field Biopsy at 12 Months
Time frame: 12 months
Number of participants with a negative biopsy in the region of the prostate that was treated with the study device at 12 months
Number of Participants With Device-related Adverse Events Through 12 Months
Time frame: 12 months
Number of participants who experienced any adverse event related to the study device during the study
9 secondary outcomes
Number of Participants With a Negative In-field Biopsy at 12 Months as Defined by the Delphi Consensus Criterion
Time frame: 12 months
Assessment of Urinary Function by Comparison of Pre- and Post-operative UCLA Expanded Prostate Cancer Index Composite
Time frame: 12 months
Assessment of Erectile Function by Comparison of Pre- and Post-operative IIEF-15 Potency Scores
Time frame: 12 months
Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics
Time frame: 12 months
Effectiveness of Therapy by Measurement of Prostate-specific Antigen (PSA) Kinetics, Percent Change From Baseline
Time frame: 12 months
Assessment of Changes in Prostate Volume
Time frame: 12 months
Assessment of Ablation Effectiveness by Evaluation of Prostate Tissue by mpMRI
Time frame: 12 months
Assessment of Need for Secondary or Adjuvant Treatment
Time frame: 12 months
Evaluation of Subject Reported Pre- and Post-operative Quality of Life, Change From Baseline to 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Coleman, MD principal investigator
Memorial Sloan Kettering Cancer Center
Arvin George, MD principal investigator
University of Michigan
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irreversible Electroporation in people with Prostate Cancer, run by Angiodynamics, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Negative In-field Biopsy at 12 Months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.