Koelis, SAS, a leader in prostate care, has announced positive interim results from the VIOLETTE trial, a multicentric Phase II study (NCT04582656) evaluating the use of its Organ-Based Tracking (OBT-Fusion) technology in targeted microwave ablation (TMA) of the prostate. The trial's findings, published in BJUI Compass, highlight the potential of the Koelis Trinity 3D Ultrasound Platform to enhance precision and minimize invasiveness in prostate cancer treatment.
The VIOLETTE trial assessed the efficacy of focal ablation of prostate cancer using a microwave needle guided by 3D image fusion into the index lesion. The trial enrolled a total of 76 patients. Interim results focused on the first 37 treated patients.
Key Findings from the Interim Analysis
The interim analysis revealed promising outcomes regarding treatment data, safety, and functional outcomes. Key findings include:
- 70% of procedures were performed transperineally.
- The median pain level was 0/10 on a Visual Analog Scale (VAS) 2 hours post-procedure.
- All patients recovered spontaneous micturition and were discharged on the same day.
- Over 100% of the tumor was covered by ablation, with DCE-MRI after 7 days showing non-vascularized prostatic tissue in 97% of patients.
- A decrease in PSA and PSA density was observed and remained stable after one month of follow-up, indicating early signs of oncological efficacy.
- No significant impact on urinary or sexual function was reported.
- 58 adverse events were reported in 22 patients, including 5 severe events that resolved by the time of analysis.
OBT-Fusion Technology
The Koelis Trinity system utilizes OBT-Fusion technology, which combines 3D ultrasound and MRI imaging to visualize the prostate in real-time and create a 3D map while recording identified lesions. This enables precise planning and guidance of treatment needles into targeted areas.
Expert Commentary
Prof. Nicolas Barry-Delongchamps, Professor of Urology at Cochin Hospital and Principal Investigator of the VIOLETTE trial, commented, "The Koelis technology not only helped to detect and characterize these tumors but also allowed precise planning for targeted treatment. As we look forward to the final oncologic results, we believe this new image-guided, needle-based technology is deemed to become an efficient and safe management option for selected patients."
Implications for Prostate Cancer Treatment
Prostate cancer remains a significant health concern for men globally. The VIOLETTE trial suggests that TMA, guided by the Koelis Trinity system, offers a minimally invasive approach with promising early oncological efficacy and minimal impact on patient quality of life. These findings could represent a step forward in personalized prostate cancer care, potentially reducing the need for more aggressive treatments in selected patients.
