Local oncologists first to enrol prostate cancer patients in phase 3 theranostics trial

Pharma News: GenesisCare oncologists have achieved a significant milestone, becoming the first to enrol and deliver patient treatment in a theranostic radiopharmaceuticals trial sponsored by Melbourne-based Telix Pharmaceuticals.

The ProstACT GLOBAL phase 3 study investigates the best standard of care with and without 177Lu-DOTA-rosopatamab (TLX591) for patients with PSMA expressing metastatic castration-resistant prostate cancer progressing despite prior treatment.

Leading the efforts at St John of God Murdoch Hospital’s Theranostics facility, Dr Aviral Singh, GenesisCare’s Clinical Head of Theranostics and Nuclear Medicine, expressed his enthusiasm, saying “We are pleased to be the first location to advance this international trial and demonstrate GenesisCare’s commitment to searching for more ways to treat advanced prostate cancer in an exciting and emerging area of medicine.”

Theranostics represents a pioneering intersection of therapy and diagnostics, utilising nuclear medicine to deliver personalised treatment. This approach uses molecular imaging with PET or SPECT scanners to detect tumour receptors. If identified, a radioactive drug can selectively target tumour cells, minimising damage to healthy tissue and reducing side effects.

In related news, Novartis ANZ recently collaborated with Queensland Health and the University of Queensland to release the Bench to Bedside report and convene a roundtable on the evolving impact of radioligand therapies. Policymakers, industry leaders, academics, and patient advocates from the Prostate Cancer Foundation of Australia (PCFA) gathered to discuss therapeutic advances like Novartis’ Pluvicto and strategies for optimising cancer care.

The discussion aligns with a recent MTPConnect report, supported by Novartis and industry partners, which underscores Australia’s readiness to lead globally in radiopharmaceutical advancements. The country’s push in this field is expected to generate significant investment and innovation.

Dr Singh added, “Our aim is to support our patients while contributing to the growing body of research in the field of Theranostics and use of radiopharmaceuticals around the world. Clinical studies are crucial in understanding more about theranostics as a safe, targeted, and individualised treatment option.”

Further highlighting the importance of this research, the Lancet Oncology Commission has identified theranostics as a rapidly growing sector in cancer treatment. The use of targeted radionuclides and radiopharmaceuticals is driving a transformative shift in precision medicine, with an expanding array of therapies under evaluation.

“This trial will study the efficacy in terms of overall and progression-free survival, safety in terms of possible adverse effects, and quality of life following treatment with this rADC agent and provide new information about its uptake within the tumours and organs through an evaluation of pharmacokinetics, biodistribution, and radiation dosimetry,” explained Dr Singh.

The study builds on earlier Phase I and II trials that examined the safety of rADC and its potential to enhance survival and quality of life. Approximately 400 patients worldwide will participate, randomised in a 2:1 ratio to receive either rADC alongside standard care or standard care alone.

Prostate cancer remains the most common cancer diagnosis among Australian men. This year, over 26,000 new cases are expected, accounting for 28% of male cancer diagnoses. Despite high survival rates for certain prostate cancer types, around 3,900 men are projected to die from the disease in 2024.

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