An investigator-initiated trial soon will evaluate Clinical Laserthermia Systems’ Tranberg Thermal therapy, a focal ablation therapy, for the treatment of prostate cancer patients who have up to medium-grade, localized tumors.
The trial will take place at the Otto-von-Guericke-University Magdeburg, in Germany, through a collaboration between the medical center and the developing company. It is expected to recruit 10 participants starting in December, after receiving formal approval from an ethics committee and the regulatory agency for clinical trials in Germany.
CLS and the University Hospital Magdeburg previously evaluated the Tranberg system in MRI-guided laser ablation protocols for the treatment of small liver metastases and tumors in more than 20 patients. Results showed the procedure was safe with no treatment-related side effects.
“I am very pleased to announce this enhanced collaboration with University Hospital Magdeburg in Germany, and to get the opportunity to work together with this skilled team to get valuable user experience and collect solid clinical data from prostate treatment with the Tranberg Thermal Therapy System,” Lars-Erik Eriksson, CEO at CLS, said in a press release.
While localized prostate cancer can be treated by the surgical removal of the entire prostate and radiation, these strategies are linked with side effects. Focus has shifted to developing therapies that can kill cancer cells more specifically, while leaving healthy prostate tissue intact.
The Tranberg Thermal therapy is a minimally invasive procedure that inserts a laser into the tumor site and delivers heat in a controlled manner, which kills surrounding cancer cells.
The system is guided by imaging methods such as MRI and ultrasounds, enabling researchers to detect the tumor site with high sensitivity and to confirm its ablation in real time. It also is equipped with real-time temperature sensors used to control the temperature and ablation procedure, which offers greater safety and precision.
In prostate cancer, the approach was deemed “well fitted for highly precise and reliable ablation,” enabling a tailored heat distribution in tumors of various sizes and shapes in bovine models of disease.
The upcoming study will be co-funded by CLS, which also will supply disposable products for the trial. The Tranberg laser unit is already installed at the hospital.
Patients will be followed for one year and the trial is expected to take 18 months to complete, meaning it should end by 2022.
“This study supports CLS’s strategy to continue to build clinical evidence for our products in the [thermal ablation] space. This is the path to secure clinical relevance and enable[s] a strong commercial development for the company,” added Eriksson.