Pivotal study of NanoKnife for prostate ablation hits enrollment goal

The enrollment target has been met for the PRESERVE trial (NCT04972097), which is evaluating the NanoKnife System for the ablation of prostate tissue in patients with intermediate-risk prostate cancer, according to AngioDynamics, the developer of the focal therapy.¹

In the open-label, single-group assignment PRESERVE study, all participants receive NanoKnife ablation of the prostate tissue. To enroll in the trial patients, had to be ≥50 years old with histologically confirmed, organ-confined prostate cancer (≤T2c).

Overall, 121 patients across 17 US clinical sites have been enrolled and treated in the trial, which was launched by AngioDynamics in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC).¹

“As diagnostic tools develop to allow earlier identification and localization of clinically significant forms of prostate cancer, there is a matching need to establish effective forms of treatment that target the disease and preserve patients' quality of life. Evidence is growing to support the use of partial gland ablation for prostate cancer as a reasonable alternative treatment strategy in carefully selected patients,” co-principal investigator Jonathan Coleman, MD, Memorial Sloan Kettering Cancer Center, stated in a press release.¹

“The PRESERVE study, studying the efficacy of irreversible electroporation (IRE) with the NanoKnife System from AngioDynamics in men with intermediate-risk tumors (Gleason Grade 3+4 and 4+3), will help to address further the validity of this therapeutic approach using a treatment, which is well tolerated and easy to apply in prostate tissue,” added Colemen who is leading the study along with his co-principal investigator Arvin George, MD, a urologic surgeon at the University of Michigan.¹

Explaining the NanoKnife technology in its press release, AngioDynamics reported that the system uses non-thermal irreversible electroporation,¹ which according to Maor et al, is a “Phenomenon in which high electrical fields are delivered across cells in short, micro to millisecond pulses. These pulses create irreversible defects (pores) in the cell membrane lipid bilayer, causing cell death through loss of cell homeostasis.”² The IRE technology enables the delivery of “precise treatment margins,” which preserves “vital structures” by maintaining the targeted tissue’s structural integrity, according to AngioDynamics.¹

In the open-label, single-group assignment PRESERVE study, all participants receive NanoKnife ablation of the prostate tissue. To enroll in the trial patients, had to be ≥50 years old with histologically confirmed, organ-confined prostate cancer (≤T2c). Patients had to have a Gleason score of 3+4 or 4+3 and a PSA level ≤15 ng/mL or a PSA density <0.2 ng/mL² if their PSA level was >15 ng/mL. Additionally, patients had to have no evidence of extraprostatic extension by mpMRI, as well as no evidence of seminal vesicle invasion by mpMRI.³

The primary efficacy end point of the PRESERVE trial is the rate of negative in-field biopsy at 12 months, and the primary safety end point is the incidence of adverse events by type and severity (CTCAE v5.0) through 12 months. The estimated primary completion date of the study is July 2024.³

"The PRESERVE study demonstrates AngioDynamics’ commitment to innovating care delivery,” Juan Carlos Serna, AngioDynamics senior vice president of clinical and scientific affairs, stated in a press release.¹ “As we mark the completion of enrollment and final treatment in the study, we take another important step towards demonstrating the NanoKnife System’s ability to expand treatment options for patients with intermediate-risk prostate cancer and advance our mission to improve patient quality of life. We appreciate the support provided by our PRESERVE study sites and the partnership with the SUO-CTC team in this important effort.”

References

1. AngioDynamics Completes Enrollment for PRESERVE Clinical Study. Published online August 3, 2023. Accessed August 7, 2023. https://www.businesswire.com/news/home/20230803091690/en

2. Maor E, Ivorra A, Rubinsky B. Non thermal irreversible electroporation: novel technology for vascular smooth muscle cells ablation. PLoS One. 2009;4(3):e4757. doi: 10.1371/journal.pone.0004757

3. National Institutes of Health US National Library of Medicine ClinicalTrials.gov. Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue (PRESERVE). First posted July 22, 2021. Last Updated August 4, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT04972097