The randomised phase III clinical trial, called Timing of Androgen Deprivation, plans to enroll 750 patients in Australia and New Zealand over the next five years.
One of the trial's principal investigators, Professor Gillian Duchesne, a member of the Cancer Council's Urological Cancer Committee and Director Radiation Oncology at Peter MacCallum Cancer Centre, says the trial aims to provide evidence to help clinicians advise patients about when they should start hormone treatment (androgen deprivation treatment) for prostate cancer following a rise in their PSA level.
"We know that androgen deprivation treatment, causes the PSA level to fall. However, we do not know whether starting androgen deprivation treatment as soon as a man's PSA level starts to rise will prolong their life more than if they delay treatment until there are other signs that their prostate cancer is progressing."
Professor Duchesne says hormone treatment for prostate cancer can cause loss of libido (sex drive), weight gain, impotence, hot flushes, swelling of the breasts, fluid retention and softening of the bones (osteoporosis).
"The side effects of androgen deprivation treatment can be quite significant, and therefore it's important that we have clear evidence about the best time to start this treatment, so we can minimize the side effects as much as possible for men with prostate cancer."
"One of the important things this clinical trial will investigate is the balance of quality of life for patients starting treatment immediately versus waiting until symptoms of the disease become evident."
"This trial will help doctors answer the 'quality' question for patients, and give them clear evidence about the most effective time to start androgen deprivation treatment."
The Australasian trial is being coordinated by The Cancer Council Victoria in 20 treatment sites. Victorian hospitals participating include Peter MacCallum Cancer Centre, Monash Medical Centre, and the Alfred, Geelong, and West Gippsland hospitals. Another 10 treatment sites will be participating in the near future.
The trial is open to men who have already had treatment for prostate cancer, and have experienced a relapse through a rising PSA but have no other symptoms that their prostate cancer is progressing. Men diagnosed with advanced prostate cancer without symptoms, who aren't having radiotherapy or surgery, are also eligible. Men who are interested in participating in the trial or who would like more information should contact their treating specialist or The Cancer Council Victoria at [email protected] .
The trial has been funded by Cancer Councils in Victoria, New South Wales, Queensland and South Australia, and has also received funding from the NHMRC and the Royal College of Radiologists.
This article edited by J. Strax April 27, 2005
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