World first surgery at Tauranga Hospital
A world first surgery undertaken at Tauranga Hospital could represent a major advance in the treatment of prostate cancer say medical experts.
The surgery, successfully conducted by urologist Dr Mark Fraundorfer, uses a pioneering localised drug delivery technology to deliver slow release drugs (e.g. bicalutamide) directly into cancerous tumours.
The surgery is part of a clinical study being carried out by US-based company Alessa Therapeutics, which has developed the slow-release technology called Biolen.
“I am honoured to be the first in the world to enrol a patient in this study,” says Dr Fraundorfer of Tauranga Urology Research.
“The introduction of the device delivering bicalutamide selectively to the prostate of my patient with a sizable tumour was a very straightforward procedure.”
The Bay of Plenty District Health Board’s Head of Clinical Campus Professor Peter Gilling is Chairman of the Data and Safety Monitoring Committee for the global clinical study. He says the technique could prove a major advance.
“It’s a very promising technology and also a proof of concept for the technique of delivering these drugs straight into the tumour,” says Professor Gilling.
“We use MRI scans to diagnose prostate cancers in our patients. Once identified, using this technology we can administer drugs straight to it, in the form of slow release pellets. It should open up a whole new way of treating prostate and potentially other cancers.”
The Biolen implant which was used in the surgery.
The surgery took place on Thursday, October 8, and all members of the Tauranga urology team, whose combined efforts helped make it possible, were thanked for their work.
The rate of prostate cancer in New Zealand is 103 cases per 100,000 men resulting in more than 3,700 annual cases. In Australia, the rate of prostate cancer is one of the highest among developed countries at 110 cases/100,000 men.
While some men with low-risk tumours choose to monitor their disease, most prostate cancer patients are treated with surgery to remove their prostate or with radiation therapy.
Both surgery and radiation treatment can have complications including urinary incontinence and erectile dysfunction.
Alessa’s Biolen implant is designed to deliver an anti-androgen drug to the target tissue in the prostate, eliminating significant side effects and improving quality of life for men living with prostate cancer while avoiding surgery or radiation therapy.
“We are excited to be conducting the first-in-man study of our revolutionary technology in patients with prostate cancer,” says Dr Pamela Munster, founder of Alessa Therapeutics.
“I am grateful for the dedicated efforts of our University of California and Alessa teams together with the research group at Tauranga Urology for reaching this important milestone.
“The findings from the Biolen-PC study will be used to support our U.S. IND (Investigational New Drug) submission to the FDA (Food and Drug Administration) for our Phase 2 trial.
"We believe this novel implant therapy will increase the treatment options for men diagnosed with prostate cancer and provide a higher quality of life while under treatment.”
The company received approval in Australia and New Zealand for the study earlier this year. The Biolen-PC study will treat a total of up to 20 men scheduled for prostate surgery for treatment of non-metastatic prostate cancer.
In addition to Dr Fraundorfer at Tauranga Urology, Professor Henry Woo, Associate Professor Peter Chin, Associate Professor Daniel Moon and Associate Professor Jeremy Grummet are all participating in the Biolen-PC study at their respective centres in Australasia.