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Phase 3 Trial Comparing IRE and SBRT for Intermediate-Risk Prostate Cancer

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Summary

NIH registered a Phase 3 clinical trial (NCT07548164) comparing two boost approaches for intermediate-risk prostate cancer patients receiving standard stereotactic body radiotherapy (SBRT): the investigational NanoKnife System using irreversible electroporation (IRE) versus continued standard SBRT boost. The trial is categorized as Phase 3 and appears in the ClinicalTrials.gov registry. This registration documents a new clinical study and does not itself impose compliance obligations on sponsors, investigators, or institutions.

“In this study we 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 people with intermediate-risk prostate cancer receiving standard stereotactic body radiotherapy (SBRT).”

NIH , verbatim from source
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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

The document is a ClinicalTrials.gov registry entry for a new Phase 3 clinical trial (NCT07548164) titled 'Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer.' The trial will evaluate whether irreversible electroporation (IRE) delivered via the NanoKnife System is as effective as standard SBRT boost for intermediate-risk prostate cancer patients. The registration provides the trial identifier, phase classification (Phase 3), conditions (Prostate Cancer), interventions (NanoKnife System and Stereotactic Body Radiation Therapy), and start date (April 23, 2026).

For sponsors, contract research organizations, and clinical investigators, this registry entry signals that a new Phase 3 comparative effectiveness study in prostate cancer radiotherapy is active. Sites interested in participating should consult the original ClinicalTrials.gov record for eligibility criteria, enrollment targets, investigator contacts, and site locations. The trial registration itself does not create regulatory obligations but establishes the official public record of the study's scope and design.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Comparing Two Different Boost Approaches in Radiation Therapy for People With Prostate Cancer

Phase 3 NCT07548164 Kind: PHASE3 Apr 23, 2026

Abstract

In this study we 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 people with intermediate-risk prostate cancer receiving standard stereotactic body radiotherapy (SBRT).

Conditions: Prostate Cancer

Interventions: NanoKnife System, Stereotactic Body Radiation Therapy

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Last updated

Classification

Agency
NIH
Published
April 23rd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Clinical trial registration Radiation therapy research Prostate cancer treatment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Medical Devices Pharmaceuticals

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