A Randomized Comparison of Immediate Versus Deferred Androgen Deprivation Therapy Using Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy.
Recurrent prostate cancer after radical radiation therapy is a common problem with often a
long interval from biochemical failure to the time of symptomatic relapse. Androgen
deprivation therapy (ADT) is the most commonly used intervention following radiation failure
and currently is often started immediately after the recognition of biochemical failure in
the absence of symptoms. ADT is associated with side effects that can impact on quality of
life. It is unclear whether ADT reduces prostate-specific mortality. There is currently
insufficient evidence on the timing of ADT with respect to prevention of prostate cancer
death and quality of life and cost particularly for men with fast and slow prostate specific
antigen (PSA) doubling times.
The general objective of the ELAAT trial is to determine the optimal timing of ADT in men
with recurrent prostate cancer after radical radiotherapy.
Consenting patients who have undergone prior radical radiotherapy for prostate cancer and
are now experiencing a recurrence will be screened for eligibility. If they are determined
to be eligible, patients will be stratified according to PSA doubling time, pre-radiation
Gleason Score, previous radical prostatectomy and clinical centre. After stratification,
patients will be randomized to immediate versus deferred ADT based on the 1:1 ratio between
the two arms.
Patients will be followed indefinitely and assessed formally at 6 month intervals after the
date or randomization. Patients will be assessed for recurrent disease (biochemical
failure), new primary cancer, complications of advanced malignancy, quality of life and
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to androgen independent disease (AID). AID is defined as the time from randomization to AID or last follow-up.
Andrew Loblaw, MD
Odette Cancer Centre - Sunnybrook Health Sciences Centre
Canada: Health Canada