Prostate Adenocarcinoma: TransCutaneous Hormones, PR09 (PATCH): A randomized controlled trial of transdermal estrogen patches versus luteinising hormone releasing hormone agonists in locally advanced and metastatic prostate cancer.

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TPS5099 Background: Contemporary androgen deprivation therapy (ADT) with luteinising hormone releasing hormone agonists (LHRH) suppresses androgen to castrate levels but also depletes estrogen (synthesised from aromatised testosterone). Sex hormone depletion results in serious long term toxicities including osteoporosis and adverse metabolic changes potentially associated with increased cardiovascular (CVS) risk. Transdermal estrogen is a compelling alternative to LHRH for achieving castrate levels of testosterone, and should avoid the CVS toxicity associated with oral estrogen by circumventing first-pass hepatic metabolism, as well as mitigating estrogen depletion related toxicities. Methods: PATCHis a multi-centre, randomised, non-inferiority trial comparing the efficacy and safety of transdermal estrogen patches (FemSeven 100 µg/24 hour, 4 patches changed twice-weekly reducing to 3 after 4 weeks) against LHRH. Men (without significant CVS disease) with advanced prostate cancer (newly diagnosed or previous radical treatment and rising prostate specific antigen) are eligible. The trial was designed for evaluation in stages. Stage 1 (n=254) showed the patches produced castrate levels of testosterone similar to LHRH without additional CVS toxicity (Langley et al. Lancet Oncology 2013;14:306-16), and had more favourable blood glucose and lipid profiles. In stage 2, a pre-planned interim analysis (n=638) reviewed by the Independent Data Monitoring Committee (June 2013) led to the decision to extend the trial, with the aim of recruiting a total of 2,150 patients, to enable the evaluation of the patch efficacy to progress seamlessly from phase II to III. The design for the extension is based on the multi-stage, multi-arm (MAMS) approach and incorporates an interim analysis before continuing to the final stage. Primary outcome measures are overall and progression-free survival. The possibility of adding a new treatment arm for a phase II evaluation of an estrogen gel is being considered. Other international groups have been approached for potential collaboration. Clinical trial information: ISRCTN70406718.

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