11 May 2022

Australian medical scientists are leading the world in prostate cancer research, following the recruitment of men with incurable prostate cancer in a world-first Phase II Clinical Trial testing the effectiveness of experimental therapy combined with immunotherapy.

If the approach proves effective, it could establish a new global standard of care, giving tens of thousands of men access to a new form of treatment that will extend their lives by keeping the deadliest forms of prostate cancer in remission.

Prostate Cancer Foundation of Australia (PCFA) Chief Executive Officer Anne Savage said PCFA has invested $1.6 million in funding for the EVOLUTION Phase II Clinical Trial to test Lutetium-177-PSMA (Lu-PSMA) and immunotherapy for treatment of advanced forms of prostate cancer that have stopped responding to other treatments.

The EVOLUTION (ANZUP 2001) trial is an investigator-initiated study sponsored and led by Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), in partnership with PCFA.

“We are on the verge of a complete transformation in prostate cancer treatment, giving men with the most aggressive and deadly forms of this disease a greater hope of survival,” Ms Savage said.

“This trial will go beyond where any other trial has gone before, exploring the next frontier in precision nuclear medicine for prostate cancer, combining Lu-PSMA with immunotherapy, which we think will be a game-changer in the treatment of advanced prostate cancer.”

Lu-PSMA therapy, also known as Lutetium177 Prostate Specific Membrane Antigen therapy, is a treatment for men with prostate cancer that has spread outside the prostate to other parts of the body.

“The drug Lutetium, on its own, binds to the cancer cells while not affecting the surrounding tissue, like radiation and chemotherapy do. It is currently considered experimental in Australia, and is typically only used when other treatments have failed.

“The EVOLUTION trial goes one step further than Lutetium on its own, pairing it with immunotherapy.

“This new class of precision medicine treatments is called Theranostics which combines therapy and diagnostics to improve our understanding of each man’s prostate cancer, and how it can be most effectively treated,” Ms Savage said.

Prostate cancer is the most common cancer among Australian men and the second most common cause of cancer-related death. About 15 per cent of those newly diagnosed have advanced prostate cancers, which have spread beyond the prostate to other areas of the body.

“This new treatment combination may lead to shrinkage or stabilisation of previously progressing tumours and therefore hopefully stop or reverse the growth of the cancer.”

Ms Savage said the ProPSMA study and TheraP clinical trials, previously co-funded by PCFA, have already vastly improved the standard of care available to men, most recently by resulting in the listing of PSMA PET/CT scanning on Medicare.

“PSMA PET/CT scanning can help to identify whether a man’s prostate cancer has spread beyond the prostate to other parts of the body, using nuclear medicine to pinpoint the prostate cancer cells, while the CT scan uses x-rays to create a 3D image of the body that can be used by specialists to get a more complete picture of each man’s situation,” she said.

The trial found this method of imaging to be 92% accurate in detecting deadly tumours, compared to only 65% accuracy for CT and bone scans combined.

“If the cancer has spread to other parts of the body, doctors use a special nuclear medicine radiotracer that attaches itself to the PSMA and deploys a form of targeted radiation to find and destroy the killer cancer cells.”

The radiotracer is Lutetium and is usually given in intervals of six weeks, with between four and six cycles of the treatment recommended.

In the EVOLUTION trial, Lu-PSMA will be given in conjunction with two immunotherapy drugs that are in common use for cancer treatment, known as ipilimumab and nivolumab.

PCFA is partnering with the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) for the 12-month trial of 100 men across Australia, who are now being recruited.

ANZUP Chairman Professor Ian Davis, said while cancer immunotherapy is already used to combat many different types of cancer, it has so far not proven successful in helping treat prostate cancer.

“The reasons for this are not known, but we believe it could be made more effective if we think creatively about how it is given,” said Professor Davies.

“Radiotherapy has been shown to help boost the immune response in other settings so it is possible that combining radiotherapy with immunotherapy might lead to more and better responses in prostate cancer,” Professor Davis said.

“PCFA’s long-term partnership with ANZUP has established Australian researchers as global leaders in this field and enabled more Australian men to live longer with prostate cancer, while undergoing new forms of treatment that have minimal side-effects compared to standard of care,” Ms Savage said.

PCFA advocated strongly to the Federal government for PSMA PET/CT scanning to be listed on Medicare, which will happen from the 1st of July.

PCFA is still advocating for Lu-PSMA treatment to be made available to all men who need it, with no out-of-pocket costs. It typically costs $10,000 per round.

The study name, EVOLUTION, is an acronym for Evaluating niVOlumab LUTetium and Ipilimumab in prOstate carciNoma.


About Prostate Cancer Foundation of Australia

PCFA is Australia’s leading community-based organisation for prostate cancer research, awareness, and support. PCFA’s vision is a future where no man dies of prostate cancer. We have three aims: to maintain our status as Australia’s leading charity fund for Australian-based prostate cancer research, to protect the health of existing and future generations of men in Australia, and to improve quality of life for Australian men diagnosed with prostate cancer.



The EVOLUTION (ANZUP 2001) trial is an investigator-initiated study sponsored and led by ANZUP. This trial has received funding in partnership with the Prostate Cancer Foundation of Australia, Bristol Myers Squibb and Novartis. This trial is a collaboration between ANZUP, the NHMRC Clinical Trials Centre at the University of Sydney and the Australasian Radiopharmaceutical Trials Network (ARTnet) with support from MIM Software Inc. and ANSTO. Bristol Myers Squibb are providing drug support for the trial.


ANZUP is the leading cancer-cooperative clinical trials group that brings together all of the professional disciplines and groups involved in researching and treating urogenital cancers and conduct high quality clinical research. ANZUP identifies gaps in evidence and areas of clinical need, collaborate with the best clinicians and researchers in GU cancer and communicate frequently and effectively with the broader community along the way. ANZUP receives valuable infrastructure support from the Australian Government through Cancer Australia.

Media contact:

Laura McKoy | M. 0435 094 788