First Interim Results of the VIOLETTE Study: A Promising Step for Focal Therapy in Prostate Cancer

Prostate cancer treatments often involve invasive procedures that can significantly affect a patient’s quality of life, including urinary incontinence and sexual dysfunction. Physicians and researchers are now exploring less invasive yet effective alternatives, such as focal therapy.

Current treatment options for prostate cancer include active surveillance, prostatectomy, radiotherapy, brachytherapy, hormone therapy, and chemotherapy. While effective, many of these treatments can have life-altering side effects, prompting the search for less invasive options.

Among these, microwave ablation is emerging as a promising option. In this article, we delve into the VIOLETTE study, which evaluates this innovative treatment modality.

Koelis and the focal treatment for prostate cancer

As a leader in prostate care, Koelis has developed the Trinity system, an advanced image fusion platform for personalized prostate management. With its needle-guidance capabilities and OBT technology, Koelis Trinity ensures precision and confidence, making it particularly suited for focal therapies like microwave ablation.

Finally, our OBT technology provides the precision needed for focal therapy¹.

The Violette study: is microwave ablation feasible, efficient and secure?

As our system and technoly are relevent for focal therapy, and as we have real prostate expertise, we have decided to offer our focal treatment energy. Our research has led us to use energies that already exist for other cancers. Microwave was an option that seemed promising. It was already used for lung, liver, kidney and thyroid.

Microwave ablation is a minimally invasive procedure for the treatment of tumors, and is used when conventional therapy such as surgery or chemotherapy cannot be performed. In microwave ablation, a small probe is guided through the blood vessels to the tumor. When it reaches the tumor, it generates a lot of heat, which “boils” the tumor, but is gentle on the rest of the organ².

We have decided to develop this energy and launched a study³: the Fostine study . It is a single-center feasibility, safety and efficacy studies of non-surgical interventional treatment of tumors directly in the prostate gland. It covers feasibility and efficacy studies 6 months after non-surgical interventional treatment of prostate cancer. Its main objective was to evaluate and validate the feasibility and accuracy of a non-surgical outpatient interventional treatment technique consisting in targeting the tumor directly in the prostate, while preserving healthy tissue, thanks to the unique and innovative technologies developed by KOELIS.

The targeted-microwave ablation procedure proved feasible for 80% of patients. In fact, for 8 out of 10 patients, complete coverage of the target area was visible on MRI at D7. In addition, no serious adverse events were reported in the entire cohort. The Fostine study demonstrated the feasibility, safety, and accuracy of microwave ablation in treating prostate tumors. Key results include an 80% success rate in achieving complete tumor coverage and no serious adverse events reported.

Building on this foundation, the VIOLETTE study, a Phase 2 multicenter clinical trial, investigates the oncological afficacy of targeted microwave ablation for intermediate-risk prosate cancer. The study’s primary endpoint is cancer-free status in the treated area 12 months post treatment. Here are some information about Violette study:

• Prospective multicenter interventional non-comparative study conducted in 7 European centers (including 6 in France)
• KOELIS is study leader and sponsor
• 76 patients included in the different centers, treated in two different ways (transperineal / transrectal)

 

Targeted Microwave ablation: the first results

The Fostine study has shown that TMA (targeted microwave ablation) is safe and feasible. Concerning the Violette study, the first intermediate results are live⁴:

-> 70% procedures were done transperineally
-> Median pain level was 0/10 on a VAS 2h after procedure
-> All patients recovered spontaneous micturition and were discharged the same day
-> Over 100% tumor was covered by ablation
-> A decrease in PSA and PSA density was observed and stable after one month follow-up, indicating early signs of oncological efficacy
-> No significant impact on urinary or sexual function was reported

Results will be published after one-year follow-up of the last patient.

These interim results confirm that TMA is a safe, effective, and minimally invasive approach, offering new hope for prostate cancer patients and advancing treatment possibilities for physicians. With ongoing research and innovation, Koelis continues to pave the way for improved patient outcomes and quality of life.

Sources :

¹ https://koelis.com/organ-based-tracking-fusion/

² https://www.primomedico.com/fr/cure/ablation-par-micro-ondes/#:~:text=L’ablation%20par%20micro%2Dondes%20est%20une%20intervention%20peu%20invasive,sanguins%20jusqu’%C3%A0%20la%20tumeur

³ https://pubmed.ncbi.nlm.nih.gov/34260598/

⁴ https://bjui-journals.onlinelibrary.wiley.com/doi/10.1002/bco2.444