RATIONALE: The increasingly prolonged and extended use of androgen deprivation therapy (ADT)
in the treatment of prostate cancer, usually achieved through the administration of LHRH
agonists, has raised concerns about long-term toxicities, in particular osteoporosis and
adverse metabolic changes which may be associated with type II diabetes and increased
cardiovascular risk. An alternative approach is to investigate other methods of ADT. Oral
oestrogen has been shown to be as effective as LHRH and surgical orchidectomy in achieving
castrate levels of testosterone and has equivalent or improved prostate cancer outcomes but
is not used routinely as first-line therapy because of the risk of cardiovascular system
(CVS) complications. The CVS complications have been attributed to first-pass hepatic
metabolism. Administering oestrogen parenterally avoids the entero-hepatic circulation and so
is expected to mitigate the risk of CVS toxicity whilst still effectively suppressing
testosterone to castrate levels. This hypothesis has been supported by results from the early
stages of this trial which have provided sufficient indication of the safety and efficacy of
the patches to warrant further investigation of the treatment in this setting, as recommended
by the IDMC..
PURPOSE: This randomized phase III trial is studying how well the estrogen skin patch works
compared with luteinizing hormone-releasing hormone agonist injections in treating patients
with locally advanced or metastatic prostate cancer.
Phase:
Phase 3
Details
Lead Sponsor:
Imperial College London University College, London
Collaborators:
Medical Research Council University College, London