Rambam Health Care Campus has launched a first-in-the-world Phase I clinical trial using cryotherapy to freeze and remove cancer cells from the bladder without damaging the surrounding healthy tissue.
“The primary goal is to lessen the risk of tumor recurrence and to improve the patient’s chance for a full recovery,” said Prof. Gilad Amiel of Rambam’s Department of Urology, who is leading the trial with Dr. Azik Hoffman.
The trial, being jointly administered by Vessi Medical - the company that developed the procedure - will involve 10 patients. The procedure was already used on two individuals last month and another two were treated on Thursday.
Bladder cancer is the fourth most common type of cancer in men in the Western World, and tends to be more common in older men. A disease often associated with smokers, Amiel said that Rambam sees “a huge number of cases,” especially in Arab men from northern Israel.
Some 50% of Arab men in Israel smoke, he said.
Another challenge with this cancer is that there is a 50% to 60% chance of recurrence so anyone diagnosed with the disease has to be closely monitored even after recovery. Amiel said patients are screened every three months for two years after treatment, every four months in year three, every six months in years four and five and yearly thereafter. If there is a recurrence, the clock resets.
Despite the large number of people who suffer from non-muscle invasive bladder cancer, in the last 40 years, very few technologies to treat it have been developed and it has been treated by an invasive surgical procedure under anesthesia in which the tumor is resected - scraped off the bladder wall leaving the surrounding healthy tissue scarred. The result can be edema, infections and even bleeding.
In the long term, the bladder can become smaller and contracted, requiring the individual to go to the bathroom very frequently.
Amiel said the surgery takes a long time, involves post-surgery hospitalization and fails to prevent disease recurrence.
By contrast, cryotherapy involves navigating a urethral catheter equipped with an advanced optical system into the patient’s bladder. Once the tumor is located, it is targeted and frozen off.
It’s ambulatory and involves no anesthesia – “a real paradigm shift,” Amiel said, noting that the cryotherapy requires only light sedation.
Cryotherapy was used in the past to treat many other forms of cancer, including lung, kidney, prostate and skin cancers. The idea for using it to treat bladder cancer was developed by Eyal Kochavi, after observing a traditional scraping procedure performed by a colleague. He launched Vessi Medical where the modality was developed. Vessi has been working with Rambam urologists for the last five years to perfect this technology.
Amiel said that the Phase I trial will involve 10 patients and is focused mostly on safety. After that, a small – some 40 patients – Phase II trial is expected to take place and then a Phase III multicenter, international trial would bring the procedure forward with the aim of Food and Drug Administration approval.
Depending on outcomes and funding, he said the process could take between two and five years.
“It is up to us to prove from an oncology standpoint that this procedure is equivalent or better to what we have now with way less suffering to the patient, ” Amiel said.