Prostate NanoKnife Surgery

 The NanoKnife System for Prostate Cancer Treatment

I. Executive Summary

This briefing document provides a comprehensive overview of the NanoKnife System, an innovative, minimally invasive, non-thermal focal therapy for prostate cancer. Developed by AngioDynamics, the NanoKnife System utilizes Irreversible Electroporation (IRE) technology to destroy targeted cancer cells while preserving surrounding healthy tissue and critical functions, offering a significant alternative to traditional radical procedures. Recent FDA 510(k) clearance for prostate tissue ablation, based on the successful PRESERVE clinical study, marks a pivotal moment for its adoption and expansion.

II. Key Themes & Important Facts

A. Technology and Mechanism of Action

• Irreversible Electroporation (IRE) Technology: The NanoKnife System employs IRE technology, which involves delivering "high-voltage pulses, creating permanent nanopores within the cell membrane." This stimulus leads to an "apoptotic-like cellular death in the targeted tissue, resulting in a complete ablation of the targeted tissue." (AngioDynamics FDA Clearance)
• Non-Thermal and Radiation-Free: A key differentiator of NanoKnife is its non-thermal approach, meaning it "effectively destroys targeted cells without the use of thermal energy." This is crucial because "thermal energy causes the non-specific destruction of both cellular and acellular contents leading to the destruction of the extracellular Matrix and the potential damage to vital structures." (The NanoKnife System, AngioDynamics FDA Clearance)
• Preservation of Vital Structures: Unlike thermal ablation methods, NanoKnife "ensures the conservation of the extracellular Matrix" and "enables the preservation of vital structures inside the ablation Zone facilitating the histological and functional regeneration of tissue following treatment." This includes major blood vessels, nerves, and bile ducts. (The NanoKnife System, NanoKnife Focal Therapy - BPH Canada, BackTable)
• Precise and Customizable Ablation: The system uses "multiple electrodes that can be used to create a focal ablation zone with precise margins." The number and "geometry of the probes and the number of probes that we use helps to dictate how the ablation zone is going to play out," allowing for tailored treatment based on lesion size and location. (BackTable, NanoKnife Focal Therapy - BPH Canada)

B. Indications and Ideal Candidate Profile

• FDA Clearance for Prostate Tissue Ablation: As of December 9, 2024, AngioDynamics received "FDA 510(k) clearance for the NanoKnife System for prostate tissue ablation." (AngioDynamics FDA Clearance)
• Intermediate-Risk Prostate Cancer: The pivotal PRESERVE clinical study evaluated its safety and effectiveness for "ablating prostate tissue in patients with intermediate-risk prostate cancer (PCa)." (AngioDynamics FDA Clearance)
• Localized Disease: NanoKnife is primarily suitable for men with "localized prostate cancer, where the cancer is confined to a specific region of the prostate." It is "not typically recommended for advanced or metastatic prostate cancer." (NanoKnife Focal Therapy - BPH Canada, Dr Troy Gianduzzo)
• Gleason Score: The ideal candidate generally has an "intermediate grade prostate cancer, ideally with a Gleason score of 3 + 4." For older patients with comorbidities, it may also be an option for "4 + 3 disease." (BackTable)
• Unilateral Disease Preferred: Physicians currently "prefer to offer the NanoKnife procedure to patients with disease in only one lobe" of the prostate. (BackTable)
• Alternatives to Radical Procedures: NanoKnife offers a "minimally invasive option for prostate treatment" for patients seeking alternatives to "conventional radical surgery or radiotherapy, which often results in significant dysfunction in urinary continence and erectile potency." (AngioDynamics FDA Clearance)

C. Clinical Efficacy and Quality of Life Outcomes

• PRESERVE Study Results: The PRESERVE study met its primary effectiveness endpoint. At 12-months post-procedure, "84.0% of men were free from in-field, clinically significant disease." (AngioDynamics FDA Clearance)
• Preservation of Function: The study demonstrated "strong quality of life outcomes with short-term urinary continence being preserved (96.6% at baseline, 95.4% at 12-months) and the ability to maintain erections sufficient for intercourse only decreasing 9% compared to baseline (80.7% to 71.7%)." (AngioDynamics FDA Clearance)
• Comparable to Prostatectomy in Cancer Control: Some sources suggest the treatment is "comparable to prostatectomy in terms of success in cancer control" while minimizing side effects. (The Focal Therapy Clinic)
• Positive Early Outcomes (Short-Term): A study published in European Urology Oncology reported "excellent outcomes with almost 100% pads-free continence, >90% with good maintenance of sexual function and ~ 90% free from a significant cancer that required further treatment" at 1 year post-treatment. However, it cautions that "these are short term outcomes, so longer term data with 10 years + followup is required." (European Urology Oncology)
• Extensive Prior Research: The PRESERVE study results "validated the robust safety and clinical efficacy profile of the NanoKnife System, reinforcing findings from more than 32 clinical studies performed around the world involving over 2,600 patients." (AngioDynamics FDA Clearance)

D. Procedure and Recovery

• Outpatient Procedure: The NanoKnife procedure is typically performed on an outpatient basis, allowing patients to "go home the same day." (North Toronto Prostate Centre Inc., NanoKnife Focal Therapy - BPH Canada)
• Anesthesia: Patients are "asleep and remain asleep until the procedure is complete," typically under general anesthesia. (North Toronto Prostate Centre Inc., Dr Troy Gianduzzo)
• Electrode Placement: "Electrodes the size of a long thin needles will be directed inserted into the prostate gland through the skin underneath your scrotum using ultrasound and MRI guidance." The number of electrodes ranges from 2 to 6. (North Toronto Prostate Centre Inc., NanoKnife Focal Therapy - BPH Canada)
• Duration: The entire procedure may be completed within "45 minutes to an hour." (BackTable, NanoKnife Focal Therapy - BPH Canada)
• Recovery: Recovery time is "generally short and limited to a few days." Patients typically require a catheter for a few days, often up to a week. (Dr Troy Gianduzzo, NanoKnife Focal Therapy - BPH Canada)
• Tissue Regeneration: "After treatment, adjacent non-cancerous cells migrate in and replace the dead cancer cells. There is some evidence that healthy cells grow back and regenerate instead of leaving a hole in the organ allowing the organ to continue to function." (Dr Troy Gianduzzo)

E. Side Effects and Risks

• Minimally Invasive with Mild Side Effects: As a minimally invasive treatment, "the side effects of NanoKnife are much less than surgery." They are "usually mild and infrequent." (The Focal Therapy Clinic)
• Potential Side Effects: These can include "dysuria (pain or burning sensation when you urinate), increased risk of contracting a urinary tract infection (due to catheter), some blood and seminal fluid in your urine" (caused by tumor breakdown), "small risk of decreased/absent ejaculatory fluid which could affect fertility," "erectile dysfunction," and "temporary urinary retention." (The Focal Therapy Clinic, NanoKnife Focal Therapy - BPH Canada)
• Lower Risk Compared to Cryosurgery: Current data suggests NanoKnife has a "lower risk for swelling, erectile dysfunction, stricture formation, and urinary retention" compared to cryosurgery. (BackTable)
• No Long-Term Data: It is important to note that "no long-term data are available on side-effects and outcomes," particularly for data extending 10 years or more. (Dr Troy Gianduzzo, European Urology Oncology)

F. Comparison with Other Focal Therapies (HIFU)

• HIFU (High-Intensity Focused Ultrasound): Both NanoKnife and HIFU are "excellent focal therapies in the treatment of prostate cancer," aiming to "target small areas of the prostate rather than the entire prostate gland" to reduce serious side effects. (Comparing NanoKnife and HIFU)
• Method of Function: HIFU "uses ultrasound waves to heat prostatic tissue and destroy cancerous prostate cells." NanoKnife "uses irreversible electroporation, a recent technology that involves deploying a short burst of electrical current to destroy the tumor without heat." (Comparing NanoKnife and HIFU)
• Accessing the Prostate: NanoKnife "deploys electrodes placed through the perineum (area of skin between the scrotum and anus)," allowing it to "target any part of the prostate." HIFU's ultrasound probe is "inserted into the rectum and treated upward to the prostate," making it "most often used for posterior lesions." (Comparing NanoKnife and HIFU)
• Insurance Coverage: As of March 2025, HIFU "has been covered under most commercial insurance plans and Medicare since 2023." Conversely, NanoKnife "will not be fully covered until January 2026," though some commercial insurance coverage has been achieved. (Comparing NanoKnife and HIFU)

G. Market Adoption and Future Outlook

• Accelerating Adoption: AngioDynamics is committed to "accelerate the adoption of the NanoKnife System, redefine the standard of care for prostate health, and deliver treatment outcomes that patients and physicians need." This includes comprehensive education and awareness campaigns. (AngioDynamics FDA Clearance)
• Global Footprint Expansion: The company aims to "expand our global footprint and increase access to our technology." (AngioDynamics FDA Clearance) The North Toronto Prostate Centre Inc. is highlighted as the "FIRST provider of the state-of-the-art NANOKNIFE IRE technology in Canada." (North Toronto Prostate Centre Inc.)
• Physician Locator: AngioDynamics provides a "Physician Locator below to find a physician near you who utilizes the NanoKnife System in their practice," including urologists, interventional radiologists, surgical oncologists, and HPB physicians. (Physician Locator Tool)

III. Conclusion

The FDA clearance for the NanoKnife System for prostate tissue ablation represents a significant advancement in prostate cancer treatment, particularly for intermediate-risk localized disease. Its non-thermal, function-preserving approach offers a compelling alternative to more invasive procedures, with promising short-term clinical outcomes regarding cancer control and quality of life. While long-term data are still being gathered, the current evidence, coupled with AngioDynamics' commitment to expanding access and education, positions NanoKnife to become a key player in redefining the standard of care for prostate health.