Introduction

In a groundbreaking advancement for prostate cancer treatment, the multicentric phase 2 VIOLETTE trial (NCT04582656) has successfully completed enrollment and published promising interim results. The trial, focused on the efficacy of organ-based tracking fusion (OBT-Fusion) technology in microwave ablation of prostate tissue, was developed by Koelis, a leader in medical imaging.

Results Presentation

Results are set to be discussed in detail at the 118th French Urology Congress in Paris, where experts will further explore the implications of this innovative technology.

Technology Overview

The VIOLETTE trial leverages the state-of-the-art Koelis Trinity® fusion imaging system, featuring OBT-Fusion technology. This cutting-edge system allows urologists to create a detailed 3D map of the prostate and accurately pinpoint lesions for targeted microwave ablation therapy. “The Koelis technology not only aided in the detection and characterization of tumors but also enabled meticulous planning for effective treatment,” expressed Barry-Delongchamps, a professor of Urology at Cochin Hospital and the trial's principal investigator. “As we await final oncological outcomes, we are optimistic that this image-guided, needle-based approach will be a safe and effective management option for certain patients.”

Interim Results

The interim results showcased significant success, with over 100% of tumors comprehensively covered by the ablation process. Dynamic contrast-enhanced MRI evaluations revealed non-vascularized prostatic tissue in 97% of patients within just one week post-treatment. Impressively, 70% of the procedures were performed via the transperineal route, with patients reporting a median pain level of 0/10 on a visual analog scale two hours after the procedure. Remarkably, all patients regained the ability to urinate spontaneously and were discharged on the same day. Follow-up assessments indicated a reduction in both prostate-specific antigen (PSA) levels and PSA density, which remained stable after one month.

Safety Profile

In terms of safety, the trial reported no substantial effects on urinary or sexual function among participants. A total of 58 adverse events were recorded across 22 patients, with only five classified as severe, all of which resolved by the time of the analysis.

Trial Details

The trial culminated in September with a total enrollment of 76 patients, focusing initially on treatment data, safety, and biological and functional outcomes from the first 37 patients treated. Eligibility for participation required patients to be between 45 and 76 years old, with a life expectancy exceeding ten years, diagnosed with intermediate-risk prostate cancer classified as either T1c or T2a, and possessing specific cancer characteristics such as a Gleason score of (3+4) or a PSA level below 20 ng/mL. Participants were screened meticulously, ensuring no significant medical or psychiatric conditions that could impede treatment or consent.

Ablation Procedure

During the ablation procedure, patients received targeted microwave therapy to the identified tumor through either a transperineal or transrectal approach. The primary outcome measured was the proportion of patients with no detectable cancer on subsequent targeted biopsy, while secondary outcomes included rates of radical salvage treatment and patient urine flow dynamics.

Research Centers Involved

The VIOLETTE trial involved multiple research centers across Bordeaux, Paris, and Nantes, and represents a significant step forward in the treatment landscape for prostate cancer.

Expert Insights

Antoine Leroy, PhD, the founder and CEO of Koelis, emphasized the global shift in prostate care, stating, “We believe precision imaging will transform the lives of millions of patients. As we aim to become the preferred partner for urologists worldwide, we are proud that the VIOLETTE trial highlights Koelis’ pivotal role in advancing focal therapy for prostate cancer.”

Conclusion

Stay tuned for more updates as the final results of the trial promise to further refine treatment options for men facing prostate cancer.