In a significant development for the field of urological oncology, medical technology firm AngioDynamics has announced promising two-year results from its PRESERVE pivotal trial. The study, which evaluates the safety and efficacy of focal irreversible electroporation (IRE) using the NanoKnife system, suggests a durable, minimally invasive alternative for patients suffering from intermediate-risk prostate cancer. As the medical community increasingly seeks to balance cancer control with the preservation of patient quality of life, these findings represent a critical milestone in the adoption of focal therapy.
Main Facts: The PRESERVE Trial at a Glance
The PRESERVE trial is a prospective, single-arm, investigational device exemption (IDE) study designed to assess the clinical outcomes of using the NanoKnife system for focal therapy in men diagnosed with intermediate-risk prostate cancer. The study focused specifically on patients with Gleason Grade Group two to three disease, a cohort that often faces difficult treatment decisions between radical surgery, radiation therapy, and active surveillance.
The study spanned 17 clinical centers across the United States, conducted in close partnership with the Society of Urologic Oncology Clinical Trials Consortium. By enrolling 121 patients, the trial sought to determine whether focal IRE—a process that uses high-voltage electrical pulses to induce cell death in targeted tumor tissues while sparing surrounding nerves and blood vessels—could offer a sustainable treatment path.
The two-year data readout indicates that the efficacy of the treatment is not only immediate but sustained. With a high retention rate of 94.4% of eligible participants (68 out of 72) completing the 24-month assessment, the data provides a robust look at the long-term viability of the procedure.
Chronology of the PRESERVE Study
The journey of the PRESERVE trial reflects the rigorous nature of modern medical device clinical validation.
- Initial Study Design and Enrollment: The trial was established to provide high-quality, US-based prospective data to complement international evidence. Enrollment focused on patients where the disease was localized enough to be targeted but aggressive enough to warrant intervention.
- The One-Year Milestone: Last year, initial results were released, showing an 80% freedom-from-treatment-failure rate among those patients who underwent protocol-mandated biopsies. This initial data established the proof-of-concept for the US patient population.
- The 24-Month Data Collection: Following the one-year success, researchers tracked the cohort for an additional twelve months. The focus shifted from initial clearance of the disease to the stability of the patient outcomes, monitoring for any late-stage recurrence or treatment-related complications.
- Current Status: With the two-year data now public, the study serves as a key pillar in AngioDynamics’ efforts to secure broader adoption and reimbursement for focal IRE therapy.
Supporting Data: Evidence of Sustained Efficacy
The data released at the 24-month mark is particularly compelling for urologists and oncologists who prioritize organ-sparing treatments. The key metrics of the study provide a multi-faceted view of the patient’s recovery and disease management:
1. Freedom from Treatment Failure
Perhaps the most critical metric for any cancer therapy is the recurrence rate. The two-year analysis revealed that no new treatment failures were observed among patients with available 24-month follow-up data. Only a single participant (1.5% of the study group) required a clinically indicated biopsy, and even in that instance, the results were negative for cancer, underscoring the high success rate of the initial focal intervention.
2. PSA Levels and Biochemical Response
Prostate-specific antigen (PSA) levels remain the primary biomarker for monitoring prostate health. The study reported that at the 24-month follow-up, 97% of patients demonstrated lower PSA levels compared to their baseline measurements prior to the procedure. This biochemical evidence suggests that the focal IRE treatment successfully addressed the cancerous tissue and reduced the overall disease burden within the prostate gland.
3. Safety and Tolerability
Safety is a primary concern for any ablation technology. The trial reported no new device- or procedure-related adverse events between the 12-month and 24-month intervals. This stability in the safety profile suggests that the long-term risks of focal IRE are minimal, which is a stark contrast to the potential side effects—such as incontinence or erectile dysfunction—often associated with radical prostatectomies or whole-gland radiation.
Official Responses and Clinical Perspectives
The leadership at AngioDynamics has expressed significant confidence in the trial’s results, viewing them as a vindication of the NanoKnife system’s role in modern oncology.
Juan Carlos Serna, the Senior Vice President of Scientific and Clinical Affairs at AngioDynamics, emphasized the importance of the long-term nature of this data. "Two years of prospective pivotal data in the US, combined with more than five years of international follow-up evidence, paints a coherent and compelling picture of sustained efficacy," Serna stated.
He further noted that the data is not merely a statistical success but a clinical one. "These results reinforce that the NanoKnife System is a clinically meaningful focal therapy option that physicians across care settings are actively incorporating into practice." By bridging the gap between local pilot studies and large-scale pivotal data, AngioDynamics is positioning the NanoKnife not as a niche tool, but as a standard-of-care contender for intermediate-risk patients.
Implications for the Future of Prostate Cancer Treatment
The success of the PRESERVE trial has far-reaching implications for both the medical device industry and the patient population.
A Shift Toward Focal Therapy
For decades, the "gold standard" for prostate cancer has often involved treating the entire gland. While effective at removing cancer, this approach frequently leads to significant morbidity. Focal therapy, enabled by systems like NanoKnife, represents a paradigm shift. By treating only the tumor while sparing the rest of the prostate, physicians can achieve oncological control while maximizing the patient’s quality of life.
Regulatory and Market Expansion
Earlier this year, AngioDynamics achieved a significant regulatory milestone by expanding the indications for the NanoKnife system across Europe. The system is now approved for soft tissue ablation in the liver, kidney, pancreas, and prostate. This expansion, coupled with the positive data from the US-based PRESERVE trial, creates a clear pathway for the company to expand its market footprint globally.
Impact on Clinical Practice
For urologists, the availability of high-quality, long-term data removes one of the primary barriers to adoption: uncertainty. As clinicians become more comfortable with the safety and longevity of the NanoKnife results, it is likely that focal IRE will move from a specialized procedure performed in select research hospitals to a more common offering in private practices and community health centers.
The Patient Perspective
For patients, the results provide hope. A diagnosis of intermediate-risk prostate cancer often triggers anxiety regarding the inevitable side effects of traditional treatment. With the validation provided by the PRESERVE study, patients have a data-backed argument to discuss focal therapy with their urologists, potentially allowing them to avoid the long-term complications associated with more invasive surgeries.
Conclusion
The two-year findings from the PRESERVE trial mark a pivotal moment for AngioDynamics and the broader urology community. By proving the durable efficacy of the NanoKnife system, the company has provided a strong foundation for the continued growth of focal therapy. As healthcare continues to evolve toward more personalized and less invasive treatments, the NanoKnife system stands at the forefront, offering a balance of oncological precision and patient-centered care that defines the next generation of cancer treatment.
As the study continues to track long-term outcomes, the medical community will undoubtedly keep a close eye on the NanoKnife system, watching to see how it reshapes the standard of care for men diagnosed with intermediate-risk prostate cancer worldwide.
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