ANZUP at ESMO 2025 – ENZARAD
ENZARAD
Background
Prostate cancer remains the most commonly diagnosed cancer in Australia and New Zealand with over 28,000 cases expected to be recorded in 2025¹,². Thanks to world class research, prostate cancer can be treated effectively for the majority of the people affected. Nevertheless, over 4,000 people every year will die due to an advanced or hard-to-treat form of prostate cancer and many more people will have life-long treatment related side-effects including morbidity associated with long-term hormonal suppression, sexual dysfunction and mental health issues³.
Metastatic castration-resistant prostate cancer (mCRPC) is a type of advanced prostate cancer that has spread to other parts of the body and no longer responds to standard hormone therapy, which is meant to lower testosterone. Even though testosterone levels are low, the cancer keeps growing. While it can’t be cured, there are several treatment options that can help slow the cancer down and manage symptoms.
About the trial
ENZARAD is a randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer.
Enzalutamide is a new hormone treatment taken as tablets. Previous trials have proven that enzalutamide improves survival and quality of life in patients with prostate cancer that have stopped responding to standard hormone treatments and chemotherapy. This large, international randomised trial will determine if treatment with enzalutamide can improve survival and quality of life in people starting radiation and hormone therapy for prostate cancer that does not seem to have spread beyond the prostate.
The trial has been led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. The trial accrued 802 people from 69 sites across Australia, New Zealand, Canada, the US, Ireland, and the UK. Recruitment closed on 30th June 2018.
The ANZUP investigator initiated studies were financially supported by Astellas, who also provided enzalutamide.
Poster presentation at ESMO 2025
ENZARAD (ANZUP 1303) – Randomised phase 3 trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high-risk, clinically localised prostate cancer. – Presented by Paul Nguyen
The findings provide strong evidence that for most patients it is not necessary to intensify therapy by adding the androgen receptor inhibitor, enzalutamide, to the standard of care (top quality radiotherapy with ADT.
Additionally, in a pre-planned subgroup analysis, ENZARAD showed that for people with the highest risk of recurrence or spread from their prostate cancer (i.e were clinically lymph node positive or those who were planned for pelvic radiation), addition of enzalutamide significantly improved metastasis-free survival defined as the time from randomisation to date of metastasis or death from any cause. These results are practice-informing with positive implications for patients guiding intensification in specific higher risk scenarios.
Prof Nick James, the discussant for the session, described ENZARAD ‘as a very important trial which defines a left hand end to benefit’ [sic] for androgen receptor pathway inhibitors and are consistent with the results seen in the STAMPEDE clinical trial.
References:
- Cancer Data in Australia, Australian Institute of Health and Welfare (AIHW) 2025
- New Zealand Cancer Registry (NZCR), Health New Zealand-Te Whatu Ora
- National Cancer Control Indicators; relative survival for prostate cancer by stage, 2011