Prostate CancerPhase 3NCT07548164
Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer
A Phase 3 study testing NanoKnife System and Stereotactic Body Radiation Therapy in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
In this study the investigators will find out whether the use of a new type of boost approach called irreversible electroporation (IRE) is as effective as the standard boost approach of radiation therapy for participants with intermediate-risk prostate cancer receiving standard stereotactic body radiotherapy (SBRT). Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- NanoKnife System and Stereotactic Body Radiation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 Apr 2026to 16 Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy proven grade group 2 or 3 (GS 3+4 or GS 4+3) cancer with all pattern 4 found only in the MRI target; systematic biopsy pattern 4 that is concordant with MRI target per investigator is permissible
- Gland size ≤ 80 cc
- Prostate MRI < rT3b disease
- IPSS < 20
- No contraindication to IRE, RT, anesthesia, or transperineal procedure
Who cannot join
- Any Grade Group ≥4 disease, or any cribriform and/or intraductal carcinoma
- Evidence of nodal or /metastatic disease on MRI and/or PSMA PET/CT
- Unfit for general anesthesia, or contraindication/hypersensitivity to required neuromuscular blocking agents
- Active urinary tract infection (UTI) at the time of IRE or biopsy; must be treated and resolved prior to proceeding
- Actively bleeding, known bleeding disorder, or inability to interrupt anticoagulants/antiplatelet therapy as clinically indicated for biopsy/IRE safety
- Any history of cardiac arrhythmia or epilepsy, or recent myocardial infarction, consistent with NanoKnife contraindication statements
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- Presence of an implanted pacemaker/defibrillator or other active implanted electronic device, or other device-related contraindications per current NanoKnife labeling/user manual
- Inability to undergo pelvic MRI
- Prior treatment of prostate cancer including androgen deprivation therapy, focal therapy, radiation therapy, or prostatectomy
- Current or intended use of androgen deprivation therapy
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Himanshu Nagar, MD, 212-639-6478
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Himanshu Nagar, MD, 212-639-6478
- Recruiting
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Himanshu Nagar, MD, 212-639-6478
- Recruiting
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Himanshu Nagar, MD, 212-639-6478
- Recruiting
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Himanshu Nagar, MD, 212-639-6478
- Not yet recruiting
Weill Cornell Medical Center (Data Collection Only)
New York, New York, 10021
Timothy McClure, MD, MS, (646) 962-6363
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Himanshu Nager, MD, 212-639-6478
- Recruiting
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Himanshu Nagar, MD, 212-639-6478
About this study
Official title: Alternative Boost Approaches in Radiation Therapy IRreversible Electroporation Versus RADIAtioN BoosT for Intermediate Risk Prostate Cancer (IRRADIANT)
In this study the investigators will find out whether the use of a new type of boost approach called irreversible electroporation (IRE) is as effective as the standard boost approach of radiation therapy for participants with intermediate-risk prostate cancer receiving standard stereotactic body radiotherapy (SBRT).
- Conditions
- Prostate Cancer
- Being tested
- NanoKnife System, Stereotactic Body Radiation Therapy
- Keywords
- intermediate-risk prostate cancer, prostate cancer, Memorial Sloan Kettering Cancer Center, 26-029
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoKnife SystemDevice
The NanoKnife System is the device that is used for Irreversible Electroporation/IRE. The NanoKnife Generator is a microprocessor-controlled low energy direct current (LEDC) irreversible electroporation device.
Stereotactic Body Radiation TherapyRadiation
Also called SBRT
Radiation-based treatment intensification involves delivery of a boost to the dominant intraprostatic lesion (DIL) to a higher dose than the surrounding prostate tissue using external beam radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| IRE Boost Arm | Experimental | Participants will receive Irreversible Electroporation Receives: Device: NanoKnife System; Radiation: Stereotactic Body Radiation Therapy |
| RT Boost Arm | Active comparator | Participants will receive Radiation Therapy and will serve as the control arm Receives: Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy negative rate at 2 years
The primary objective is to demonstrate that Irreversible Electroporation/IRE boost is non-inferior with respect to negative biopsy rate at 2 years compared to Radiation Therapy/RT boost. This is measured by the two-year biopsy negative rate for the control group and the intervention group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start16 Apr 2026
- Primary completion16 Apr 2029 (estimated)
- Study completion16 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Angiodynamics, Inc.
- Responsible party
- Sponsor
- Investigators
- Himanshu Nagar, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548164
- Sponsor's protocol ID
- 26-029
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Boost Approaches in Radiation Therapy IRreversible Electroporation Versus RADIAtioN BoosT for Intermediate Risk Prostate Cancer (IRRADIANT)
- ClinicalTrials.gov ID
- NCT07548164
- Acronym / sponsor ID
- 26-029
- Conditions
- Prostate Cancer
- Keywords
- intermediate-risk prostate cancer, prostate cancer, Memorial Sloan Kettering Cancer Center, 26-029
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Angiodynamics, Inc.
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 16 Apr 2029 (estimated)
- Study completion
- 16 Apr 2029 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators will find out whether the use of a new type of boost approach called irreversible electroporation (IRE) is as effective as the standard boost approach of radiation therapy for participants with intermediate-risk prostate cancer receiving standard stereotactic body radiotherapy (SBRT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRE Boost Arm | Experimental | Device: NanoKnife System, Radiation: Stereotactic Body Radiation TherapyParticipants will receive Irreversible Electroporation |
| RT Boost Arm | Active comparator | Radiation: Stereotactic Body Radiation TherapyParticipants will receive Radiation Therapy and will serve as the control arm |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy proven grade group 2 or 3 (GS 3+4 or GS 4+3) cancer with all pattern 4 found only in the MRI target; systematic biopsy pattern 4 that is concordant with MRI target per investigator is permissible
- Gland size ≤ 80 cc
- Prostate MRI < rT3b disease
- IPSS < 20
- No contraindication to IRE, RT, anesthesia, or transperineal procedure
Key exclusion criteria (10 listed)
- Any Grade Group ≥4 disease, or any cribriform and/or intraductal carcinoma
- Evidence of nodal or /metastatic disease on MRI and/or PSMA PET/CT
- Unfit for general anesthesia, or contraindication/hypersensitivity to required neuromuscular blocking agents
- Active urinary tract infection (UTI) at the time of IRE or biopsy; must be treated and resolved prior to proceeding
- Actively bleeding, known bleeding disorder, or inability to interrupt anticoagulants/antiplatelet therapy as clinically indicated for biopsy/IRE safety
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 |
|---|---|---|
| NanoKnife SystemThe NanoKnife System is the device that is used for Irreversible Electroporation/IRE. The NanoKnife Generator is a microprocessor-controlled low energy direct current (LEDC) irreversible electroporation device. | Device | IRE Boost Arm |
| Stereotactic Body Radiation TherapyAlso: SBRTRadiation-based treatment intensification involves delivery of a boost to the dominant intraprostatic lesion (DIL) to a higher dose than the surrounding prostate tissue using external beam radiation therapy. | Radiation | IRE Boost Arm, RT Boost Arm |
Primary outcome
Biopsy negative rate at 2 years
Time frame: 2 years
The primary objective is to demonstrate that Irreversible Electroporation/IRE boost is non-inferior with respect to negative biopsy rate at 2 years compared to Radiation Therapy/RT boost. This is measured by the two-year biopsy negative rate for the control group and the intervention group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Himanshu Nagar, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NanoKnife System and Stereotactic Body Radiation Therapy in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 8 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Himanshu Nagar, MD (212-639-6478, nagarh1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy negative rate at 2 years (time frame: 2 years). 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 18 Sep 2026.