21 February 2018

Wednesday 21 February 2018: The first of 200 patients has been enrolled on an Australian-first nuclear medicine treatment for men with advanced prostate cancer.

The TheraP trial, which is now open at Peter MacCallum Cancer Centre and Royal Brisbane and Women’s Hospital, is a partnership between ANZUP Cancer Trials Group Limited (ANZUP) and Prostate Cancer Foundation of Australia (PCFA). Please click here to view a list of other sites that have since been opened.

Prostate cancer remains the most common cancer in Australian men and the leading cause of cancer related-mortality for men in developed countries.

Many prostate cancers have a substance on their cell surface called prostate specific membrane antigen (PSMA). Lutetium-177 PSMA617 (LuPSMA) is a radioactive molecule that, after injection into a vein, specifically attaches to cells with high amounts of PSMA on the surface of the cells. This allows the radioactivity to be delivered mainly to the prostate cancer cells wherever they have spread, while sparing most normal tissues.

The study chair, Associate Professor Michael Hofman, recently presented pilot data demonstrating promising activity of LuPSMA in men who progressed after conventional therapies at the European Society of Medical Oncology (ESMO) scientific meeting.

The new randomised phase 2 study will compare treatment with the radioactive molecule Lu-PSMA against cabazitaxel chemotherapy for men with advanced prostate cancer. Outcomes of the two treatments will be measured in terms of shrinking the cancer, improving pain, delaying the time until the cancer grows again, effects on quality of life, safety, and how long men survive after the treatment.

The Australian Nuclear Science and Technology Organisation (ANSTO) is supporting the trial through provision of Lutetium-177 (Lu-177) – a nuclear medicine produced using Australia’s multipurpose reactor, OPAL. Combined with a network of hospitals with advanced nuclear medicine facilities, Australia is leading the world in clinical development of this novel treatment.

Mark Moore, General Manager at ANSTO Health, said that the trial will advance understanding of the effectiveness of Lu-177 PSMA.

"As the only manufacturer of Lutetium-177 in Australia, ANSTO is proud to be supporting this very important trial and to partner with ANZUP, PCFA and the wider clinical community to develop potential new treatment options for Australian men."

ANZUP Chair Professor Ian Davis said the trial has only been made possible thanks to the partnership with PCFA and the support of ANSTO and Endocyte (as suppliers of one of the components of the molecule).

"We know clinical trials are the only way to find out how well new treatments work, whether they are safe, and whether they should become the new gold standard for treatment in the future," said Prof Davis. "However they take a lot of investment to progress to activation and we are extremely grateful to our partners in enabling us to launch this study."

PCFA Chief Operating Officer, Malcolm Freame said the trial opening is a landmark moment.

"Getting this innovative trial off the ground has not been easy but the determination of everyone involved has paid off. We are delighted to partner with ANZUP on a study that could put Australia at the forefront of advanced prostate cancer treatment."

"I would also like to acknowledge the funding support of the Distinguished Gentleman’s Ride, Movember, It’s a Bloke Thing and CAN4CANCER in helping to make this important trial a reality."

The first patient enrolled marks the start of the journey to recruit and follow up 200 eligible patients via 10 Australian cancer centres.

For more information about how Lu-PSMA works, see A/Prof Michael Hofman discussing the TheraP trial with Prof Ian Davis at the 2017 ANZUP Annual Scientific Meeting.

A list of Frequently Asked Questions with answers about the Lutetium-PSMA (Lu-PSMA) prostate cancer trial is available here http://www.anzup.org.au/content.aspx?page=lutetiumprostatecancertrial.

Australian-first nuclear medicine treatment