13 November 2023

A Perth man with an aggressive form of prostate cancer has become the first patient in the world to start treatment in a Phase 3 clinical trial using a new form of nuclear medicine.

Should it prove effective, the treatment could extend the lives of thousands of Australian men each year, preventing avoidable deaths from prostate cancer.

Prostate Cancer Foundation of Australia Chief of Mission and Head of Research, Professor Jeff Dunn, said Australia was leading the world in prostate cancer research.

“Australia has one of the highest rates of prostate cancer in the world – with more than 25,000 Aussie men diagnosed each year.

“Tragically, more than 3,700 men die from the disease each year, taking an immeasurable toll on lives.

“While the disease enjoys a relatively high survival rate, we welcome research such as this, which could help us cover the last mile to a cure.”

Professor Dunn commended the team driving the research.

“Impressively, this trial is being driven by an Australian-headquartered company and led by Australian-based researchers, using therapeutic agents in a novel combination with real world standard of care.

“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.

“Australia is a world leader in this field and our hope is that more Australian men will survive their disease as a result.”

At a broad level, the researchers are investigating an emerging field of nuclear medicine known as PSMA theranostics.

The trial called ProstACT GLOBAL is sponsored by Melbourne-headquartered Telix Pharmaceuticals and driven by Telix’s global medical and clinical operations team. The first patient is being treated at GenesisCare's centre at the St John of God Hospital Murdoch campus in Western Australia.

“Theranostics combines therapy and diagnostics to improve our understanding of each man’s prostate cancer, and how it can be most effectively treated,” says Dr Colin Hayward, Group Chief Medical Officer at Telix.

“The therapeutic agent we are trialing here is attracted to prostate-specific membrane antigen, a protein found on the surface of prostate cancer cells. After being injected into the blood stream, the drug can track down rogue prostate cancer cells in other parts of the body.

“This research uses a special nuclear medicine radiotracer known as lutetium therapy that attaches itself to the PSMA and deploys targeted radiation to destroy the killer cancer cells. 

“Notably, this trial is the first phase 3 study of a therapeutic agent using an antibody as a targeting molecule, known as a radio-antibody drug conjugate (or rADC for short).

“Until now, nuclear medicine therapies like this have relied on small molecules, which require higher doses compared to using an antibody as the targeting molecule.

“Previous studies have shown that this antibody attaches to the tumour for longer, lengthening the therapeutic duration, meaning greater potential effect on cancerous cells.

“The objective of the study is to investigate and confirm the risks and benefits associated with Telix’s TLX591 candidate administered together with Standard of Care (SoC), as compared to SoC alone.

Professor Nat Lenzo, GenesisCare Group Clinical Director Theranostics and Principal Investigator on the ProstACT GLOBAL study said the antibody approach has the potential to make a meaningful difference in cancer treatment.

“It is really exciting to see further development of this PSMA-targeting radiotherapeutic and we are pleased to have initiated this phase 3 study here in Perth, Western Australia.”

“An antibody approach helps reduce excretion of the agent in the patient’s urine, as well as having reduced salivary gland toxicity, which can be a side effect of nuclear medicine therapies based on small molecule targeting agents.

“Previous studies have confirmed the suitability of the short, simple treatment duration with two doses administered two weeks apart.

“I have also been encouraged with the safety profile, tolerability and early efficacy observed to date, in particular for symptom control.”

Prostate cancer is the leading cause of cancer-related hospitalisations in Australia, accounting for nearly 1 in 10 of all cancer-related hospitalisations.

Treatment of the disease in Australia costs more than $1.35B every year.

Worldwide, more than 1.4 million men are diagnosed with prostate cancer each year and more than 375,000 die from the disease.


Key statistics

  • Prostate cancer is the most commonly diagnosed cancer in Australia and the most commonly diagnosed cancer among Australian men.
  • 25,487 Australian men will be diagnosed with prostate cancer in 2023.
  • 3,743 Australian men will die from prostate cancer in 2023.
  • Around 70 Australian men are diagnosed each day with prostate cancer, and more than 10 Australian men will die each day from the disease.
  • Around 16% of men (n=4024) are newly diagnosed with late-stage (Stage 3 or 4) disease every year.
  • 250,958 Australian men are alive today after a diagnosis of prostate cancer between 1982 and 2018.
  • Men diagnosed with prostate cancer have a 95.6% chance of surviving for five years compared to their counterparts in the general Australian population.
  • Between 1982 and 2018, five-year relative survival for prostate cancer improved from 58% to 95.6%.

Detailed data

  • Prostate cancer is the 2nd most common cause of death from cancer in Australian men, behind lung cancer.
  • Prostate cancer causes an estimated 13% of all male deaths from cancer in Australia.
  • The estimated risk of a man being diagnosed with prostate cancer by age 85 is 1 in 5.
  • The estimated risk of a man dying from prostate cancer by his 85th birthday is 1 in 22.
  • The rate of men dying from prostate cancer in Australia has been gradually falling over the past 20 years.
  • Men living in regional or rural areas of Australia have approximately 24% higher rate of dying from prostate cancer than their urban counterparts.
  • Indigenous Australian men face a 50% increased risk of prostate cancer mortality compared to non-Indigenous men.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com for more information about Telix and follow Telix on LinkedIn.

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