Clinical Trial Breakthrough Shared Globally

ANSTO

ANSTO congratulated the Peter Macallum Cancer Centre led team, who recently reported the remarkable results of late-stage prostate cancer clinical trials at an international conference this month.

The nuclear medicine manufacturing group has been producing the lutetium-177 (n.c.a. Lu-177) in the OPAL multipurpose reactor for clinical trials since 2015.

Report from Peter Mac website

A targeted radioactive infusion that is a game-changer in late-stage prostate cancer can also dramatically improve outcomes for patients in earlier stages of this disease, a Peter Mac-led study has shown.

Lutetium-177 PSMA-617 - or LuPSMA - therapy had been shown in previous clinical trials to extend lives, and improve quality-of-life, in patients with advanced metastatic prostate cancers who have exhausted all other treatment options.

The UpFrontPSMA study was the first to test this treatment in patients with newly diagnosed prostate cancers that had spread. The trial's "remarkable" results were simultaneously published overnight in the leading journal Lancet Oncology and presented at Europe's major cancer conference - ESMO (European Society for Medical Oncology) Congress 2024.

Peter Mac was the leading recruitment site for this Phase II trial, which enrolled 130 people from 11 Australian hospitals. All participants received androgen deprivation therapy - starving their prostate cancer of the hormone it uses as fuel - and they were then randomised to receive chemotherapy alone (the standard-of-care) or chemotherapy plus LuPSMA.

Lu-177 arun azad

Adding LuPSMA therapy to the standard-of-care approach was seen to dramatically improve responses compared to chemotherapy alone," explains Associate Professor Arun Azad (pictured above), who presented the results at ESMO 2024 in Barcelona.

"We looked for undetectable PSA - a marker for prostate cancer - at 48 weeks after treatment and this was achieved in 41% of patients who received LuPSMA compared to just 16% for the standard-of-care.

"This is a remarkable result however before we can say this should change clinical practice, we need to see this replicated in a larger Phase III clinical trial and, thankfully, a trial like this is already underway globally."

Benefits were also seen across a range of progression-free survival measures, while adverse events were equivalent in either treatment approach and linked mostly to chemotherapy.

UpFrontPSMA was funded by the Prostate Cancer Research Alliance (PCRA) - involving Movember and the Australian Government's Medical Research Future Fund, with support from Novartis and a US Department of Defense grant.

Movember's Director of Prostate Cancer Research, Sam McKeown says: "Movember are proud to have supported this research through the Prostate Cancer Research Alliance. With prostate cancer cases set to double by 2040, research into preventing high-risk prostate cancer from progressing to fatal disease is critical".

Professor Michael Hofman, who leads the Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) at Peter Mac, adds: "The exciting results we have seen in the UpFrontPSMA trial validate the PCRA's approach of supporting high-risk, high reward clinical trials".

The trial was also supported by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group. ANZUP CEO Associate Professor Samantha Oakes says: "ANZUP is extremely proud of this world first study, and the results are clear that adding LuPSMA to standard of care is improving lives of people with advanced metastatic prostate cancer."

The radioactive isotope Lutetium 177 that underpins this therapy is produced and supplied by ANSTO from its nuclear medicine precinct in Sydney. ANSTO produces 80 per cent of Australia's nuclear medicines used in the diagnosis, staging, and treatment of various medical conditions and diseases, including cancer.

The Lancet Oncology paper is titled "Sequential [177Lu]Lu-PSMA-617 and Docetaxel versus Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer (UpFrontPSMA): a multicentre, open-label, randomised, phase 2 study". Read the paper in full here.

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