Early data from the PATCH trial in the UK

Since 2007 a randomized clinical trial in the UK (the so-called PATCH trial) has been comparing the effectiveness and safety of transdermal estradiol patches to implants of an LHRH receptor agonist (goserelin acetate) in the treatment of advanced prostate cancer.

The long-term outcomes of the PATCH trial are still unknown, but what have now been published (by Gilbert et al.) are the results of an analysis of the quality of life (QoL) of participants in the PATCH trial over the initial 6 months of their treatment.

The randomized, multi-center PATCH trial, to date, has enrolled > 700 men with locally advanced or metastatic prostate cancer who were considered to be appropriate candidates for androgen deprivation therapy (ADT). The patients have been treated with either a standard form of LHRH therapy (according to the practices of the local hospitals where they were being treated) or with three or four transdermal patches containing 100 μg of oestradiol/24 hours.

In the current portion of this study, the patients were all asked to complete QoL questionnaires, and the main study outcome was the overall QoL score at 6 months, compared between patients in the two arms of the trial.

Here are the top-line data reported by Gilbert et al.:

  • 727 men were enrolled into the PATCH trial between August 2007 and 5 October 2015.
    • 412/727 men (56.7 percent) were randomized to treatment with transdermal estradiol.
    • 315/727 men (43.3 percent) were randomized to treatment with an LHRH receptor agonist.
  • Baseline characteristics were found to be comparable between the patients in the two arms of the trial.
    • Average (medain) age was 74 years.
    • Average (median) PSA at time of trial enrollment was 44 ng/ml.
    • 294/727 patients (40.4 percent) had metastatic prostate cancer.
  • After 6 months on treatment, compared to reported data at baseline, the patients being treated with transdermal estradiol (as compared to the patients being treated with an LHRH receptor agonist) reported
    • A higher global QoL (mean difference +4.2, p = 0.006)
    • Less fatigue
    • Improved physical function
    • Less likelihood of hot flashes (8 vs 46 percent)
    • A slightly lower lack of sexual interest (59 vs 74 percent) and level of sexual activity
    • Higher rates of significant gynecomastia or enlargement of the breasts (37 vs 5 percent)

Gilbert at el. suggest that greater risk for hot flashes among men being treated with LHRH receptor agonists may help to explain both the lower global QoL and the increased fatigue in the patients in this arm of the trial as compared to those in the transdermal estradiol arm.

According to information about this trial on the ClinicalTrials.gov web site, the trial is ongoing, is scheduled to enroll a total of 2,200 men, and is expected to report efficacy and safety data in about 2021. However, this trial is exclusively available to men being treated in the UK.

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