Prostate cancer drug trials seek better treatments

In the campaign to produce better treatments with fewer side effects, Flinders University researchers are conducting innovative trials, including a  trial to test a new treatment capable of killing cancer cells left behind after prostate removal surgery.

Flinders Centre for Innovation in Cancer clinical trials are also seeking participants for the study to investigate the efficacy of two combined known medications – metformin and sodium valproate – respectively approved in Australia to treat other health conditions.

Flinders medical oncologist Dr Ganessan Kichenadasse says there is evidence that they could be used together to treat prostate cancer – possibly to replace existing treatments with harsh side effects.

Prostate cancer is the most commonly diagnosed cancer in men in Australia with almost 20,000 diagnoses and close to 3,500 deaths each year.

This means that more Australians die of prostate cancer than breast cancer each year, even though prostate cancer and health check remain a taboo subject among many Australian men.

The new Flinders trial, called Sodium Valproate/Metformin Combination as neoadjuvant therapy for prostate cancer, or the VIPER 1 trial, aims to improve outcomes for men who are having radical surgery for prostate cancer.

“While this combination of MET+VPA is an experimental treatment for prostate cancer, we have good reason to be confident,” says Dr Kichenadasse.

“Laboratory studies performed by our research group identified that when these two drugs are combined, the number of prostate cancer cells killed increases significantly.”

Under the VIPER 1 clinical trial, participants take the medications – commonly used for diabetes and epilepsy respectively –  twice daily over a four-week period before they undergo prostate removal surgery.

After surgery, their PSA levels will be monitored for eight weeks to record the effectiveness of the combined medications in killing any remaining cancer cells.

Registration for this trial can be found online. Dr Kichenadasse says the trials will not interfere with existing or ongoing treatments.

Clinical oncologist Dr Ganessan Kichenadasse at the Flinders Centre for Innovation in Cancer, Bedford Park.

This research builds on an international trial also running at Flinders for improving metastatic prostate cancer treatment.

Called the ENZAMET trial, it seeks to compare the performance of new drug Enzalutamide against Bicalutamide, which is already on the market.

The trial aims to improve on current best standard treatment, which involves androgen deprivation therapy (ADT). Androgens are a group of hormones (including testosterone) that are mainly made in the testicles and control the sexual development of males.

Prostate cancers use androgens to help them grow and spread, so blocking the production of androgens can help stop the cancer growing and can make it shrink.

Prostate cancer patient Dean Dimmock is among 85 SA participants in the ENZAMET trial.

He is 2½ years into the five-year trial, and says he is pleased to be a part of the development of a potentially better hormonal treatment for prostate cancer.

“I’m happy to give anything a try to beat this disease, and I’m happy to stay on this trial if it can make a difference in the long run,” says Mr Dimmock. “If it can help others in a similar situation, it will be a great thing.”

The ENZAMET randomized test, involving 1100 participants from Australia, New Zealand, Canada, Ireland and other countries, requires taking four 40mg Enzalutamide capsules by mouth once a day.

Recent studies show promising results with the use of enzalutamide in patients with advanced prostate cancer who had been previously treated with ADT and were no longer responding to the standard anti-androgens.

Registration for this trial can be found online.

Outcomes from these Flinders trials will help determine which prostate cancer treatments are the most cost effective for the community, and beneficial to patients and their families.

For the past decade, the Prostate Cancer Foundation of Australia’s Prostate Cancer Awareness Month (September) has been a focus to promote more men to conduct regular prostate health checks and to shine a spotlight on innovative research into the disease and possible cures.

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