Scientists sit-up for world-first clinical trial into prostate cancer

Media Release 10 June 2021

Scientists sit-up for world-first clinical trial into prostate cancer

The nation’s leading prostate cancer researchers have announced a ground-breaking Phase II clinical trial which could help prevent the deaths of more than 3,100 Australian men every year.

The trial will be led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group

(ANZUP) with co-funding from Prostate Cancer Foundation of Australia (PCFA).

Known as EVOLUTION, it will be the first clinical trial of its kind to test the effectiveness of a new generation of radiotherapy treatment with existing forms of immunotherapy, which has previously failed in treating prostate cancers.

PCFA CEO Professor Jeff Dunn AO said the project was leading the world in prostate cancer research.

“The Phase II EVOLUTION Clinical Trial could lead to major advances in the treatment of advanced prostate cancer around the world, helping to prevent the deaths of more than 3,100 Australian men each year from this disease,” Prof Dunn said.

“ANZUP’s world-leading team of researchers, working with treatment centres to recruit patients around the country, will investigate whether immunotherapy, when partnered with Lutetium-177-PSMA (Lu-PSMA), can deliver life-saving results for men. “Right now, we have no way of defeating aggressive forms of prostate cancer, which impose an incredibly heavy burden on men and their families, who commonly have to endure the fear and distress of not knowing how quickly the cancer will spread.

“The EVOLUTION Clinical Trial will help us to evaluate whether radiotherapy and immunotherapy combined can create a new pathway for combatting prostate cancer once and for all.

“Around 17,000 men are diagnosed with prostate cancer each year in Australia, and more than 3,100 men will die – it is a disease that takes a tragic toll on our lives.

“We are committed to funding ground-breaking projects that save lives.”

Next week is PCFA’s Sit-Up 45 Challenge, calling on Aussies to do 45 sit-ups a day during Men’s Health Week (June 14-20) to raise vital funds for PCFA and the EVOLUTION Clinical Trial.

ANZUP Chair Professor Ian Davis urged Australians to support prostate cancer research.

“The Phase II EVOLUTION Clinical Trial simply wouldn’t be possible without funding from organisations such as PCFA,” Prof Davis said.

“We are proud to see PCFA launch the Sit-Up 45 Challenge, to help continue this work. “I would urge all Australian men and women who want to make a difference in our fight against prostate cancer to support our work by registering for the Sit-Up 45 Challenge via situp45.org.au.

“The challenge calls on people to do 45 daily sit-ups during the week in solidarity with the 45 Australian men who are diagnosed with prostate cancer every day.

“Sit-up to prostate cancer and help us fund the EVOLUTION Clinical Trial to eliminate a silent killer in our community.”

Aussies can still get involved in Sit-Up 45 by registering at www.situp45.org.au.

The EVOLUTION Clinical Trial sites and patient eligibility guidelines will be announced later this year. The project will monitor and compare PSA levels for 12 months in response to the clinical trial treatment, capturing tissue samples to analyse patient responses.

With one Australian man diagnosed every 30 minutes, there are estimated to be 230,000 Australian men alive today who have been impacted by prostate cancer.

For more information about PCFA, visit www.pcfa.org.au or call 1800 22 00 99.

The EVOLUTION clinical trial sites and patient eligibility guidelines will be announced later this year. The project will monitor and compare PSA levels for 12 months in response to the clinical trial treatment, capturing tissue samples to analyse patient responses. With one Australian man diagnosed every 30 minutes, there are estimated to be 230,000 Australian men alive today who have been impacted by prostate cancer.

Kidney Cancer: RAMPART (ANZUP1606)

Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART): An international investigator-led phase III multi arm multi stage multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse.

Removing the kidney (or part of a kidney) by surgery is currently the best treatment if you have kidney cancer. The current standard treatment after surgery is ‘active monitoring’. This means no further treatment, but having regular checks, so that if the cancer does come back, further treatment options can be considered as early as possible.

Surgery, together with ongoing regular follow-up and observation, is the standard approach for people diagnosed with kidney cancer that has required removal of the kidney (or part of a kidney) by surgery. For some people the cancer may return which is when other treatment is offered. We are aiming to find out whether taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) can prevent or delay kidney cancer coming back.

It is anticipated that 1750 participants will be enrolled in this study in Australia, New Zealand, UK, France, USA and other countries.

It has been shown to be effective in treating a number of different types of cancer, particularly when used in combination with other cancer treatments.

Other drugs similar to those in this study have been shown to be effective in people with more advanced kidney cancers. In Australia, nivolumab (a drug similar to durvalumab) used by itself or in combination with ipilimumab (a drug similar to tremelimumab) are current approved treatments for people with kidney cancer that has spread outside the kidney. They are not approved for treatment of kidney cancer that has been removed, like yours.

Given similarities in the mode of action to these drugs, and based on prior research findings, we think durvalumab and tremelimumab are worthwhile drugs to test for patients to see if it will prevent or delay kidney cancer returning. “Most kidney cancers can be cured by removing them surgically, but some are destined to come back again. Many treatments have been tested to see if that risk of cancer recurrence can be reduced but until recently none had worked, so the standard of care is to watch our patients carefully after surgery and offer additional treatment if the cancer does come back. We know treatments that activate the immune system can be effective in kidney cancer that has spread, and have been shown to reduce the risk of cancer recurrence after surgery in other types of cancer. RAMPART will test two different ways of activating the immune system compared to our best standard of care, to see if this treatment is effective in reducing the risk of kidney cancer recurrence. Information presented in 2021 at a major cancer conference using a similar but different approach gives support to the idea that this question should be tested.”

RAMPART Principal Investigator (Australia), Professor Ian Davis

Durvalumab is a type of treatment called an immunotherapy, and may sometimes be referred to as an ‘anti-PDL1 drug’ or ‘immune checkpoint inhibitor’. It works by helping your own immune system to attack the cancer.

Durvalumab is currently being tested by itself or in combination with other treatments in many types of cancer. Early studies have shown that durvalumab works well and has side effects that can usually be controlled.

Durvalumab has been studied in clinical trials involving more than 13,000 people with various cancer types. It has been shown to be effective in some settings but has not been tested yet in people with kidney cancer that has been removed. Tremelimumab is another immunotherapy treatment for cancer. It may sometimes be called an ‘anti-CTLA4 drug’ or ‘immune checkpoint inhibitor’. It also works by helping your immune system to attack the cancer.

Tremelimumab has been studied in clinical trials in over 1,500 people.