COMPLETE TITLE: USANZ: The 'Timing of androgen deprivation therapy in incurable prostate cancer' protocol (TOAD) - where are we now? Synopsis of the Victorian Cooperative Oncology Group PR 01-03 and TransTasman Radiation Oncology Group 03.06 clinical trial
OBJECTIVES: To outline the development of the TOAD (Timing of Androgen Deprivation) protocol, a collaborative randomised clinical trial under the auspices of the Cancer Council Victoria, the Trans Tasman Radiation Oncology Group, and the Urological Society of Australia and New Zealand, which opened to recruitment in 2004.
PATIENTS AND METHODS: The principal hypothesis for the trial was that the early introduction of ADT (experimental arm) at the time when curative therapies are no longer considered an option, would improve overall survival for these patients, whilst maintaining an acceptable quality of life; compared to waiting for disease progression or the development of symptoms (control arm). An increase in overall survival at five years of 10% was judged to be clinically worthwhile.
RESULTS: Recruitment was slow, with fewer than half of the protocol requirement of 750 patients eventually accrued, but nonetheless it is considered that the trial will still contribute a major source of evidence in this area. The study closed to follow-up at the end of 2013, with data analysis commencing mid-2014, and with the primary publication anticipated to be submitted by the end of 2014.
CONCLUSIONS: The question of timing of androgen deprivation still remains relevant in the current era of newer and more varied treatment modalities. Even with the advent of novel chemotherapy and the biological agents which are undergoing investigation for progressively earlier disease stages, the dilemma of when to commence palliative treatment in an asymptomatic patient will remain, unless or until these agents are shown to increase overall survival. The TOAD trial will contribute to answering at least in part, some of these questions.
Duchesne GM, Woo HH. Are you the author?
Professor of Radiation Oncology, Sir Peter MacCallum Department of Oncology, Melbourne University.
Reference: BJU Int. 2014 Jul 22. Epub ahead of print.