ESTRACISE: Transdermal E2 in ADT-Induced Adverse Effects

What is it about?

The ESTRACISE study is a Phase IIA randomised controlled clinical trial that aims to offer crucial novel managing strategies for ADT-induced adverse effects in PCa patients. It is the first randomised controlled trial estimating the efficacy of transdermal E2 in mitigating the deterioration of sexual function caused by ADT. The study will recruit 310 patients with high-risk PCa who are scheduled for EBRT with adjuvant subcutaneous ADT leuprorelin. The primary endpoint of the ESTRACISE study is the efficacy of transdermal E2 in mitigating the deterioration of sexual function caused by ADT, quantified through comparison of the Expanded Prostate Cancer Index Composite (EPIC-26) sexual function domain scores between the main arms. The study uses several questionnaires to gather subjective data, including the EPIC-26, WHOQOL-BREF, PHQ-9, and training logs and diaries. The sample size for the ESTRACISE study was determined based on a priori power analysis, considering the primary outcome of the efficacy of transdermal E2 in mitigating the deterioration of sexual function caused by ADT. The analysis is based on the sexual domain scores of the EPIC-26 questionnaire.

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Why is it important?

This research is important because it provides new insights into the benefits of transdermal estrogen (E2) gel in managing the adverse effects of androgen deprivation therapy (ADT) in patients with high-risk prostate cancer (PCa) undergoing external beam radiation therapy (EBRT). The study offers a novel approach to managing the side effects of ADT, which can significantly impact a patient's quality of life. The findings can contribute to the development of more effective treatment strategies for PCa patients undergoing ADT. Key Takeaways: 1. The ESTRACISE study is the first randomized controlled trial to evaluate the efficacy of transdermal E2 in mitigating the deterioration of sexual function caused by ADT. 2. The study uses a low dose of E2 (0.75 mg daily) that is evidence-based and likely minimizes adverse effects. 3. Supporting the chosen dosage, a study showed that even lower E2 doses effectively alter E2 levels, which validates the 0.75-mg daily dose. 4. The substudy can reinforce the benefits of resistance training and deliver valuable new insights about the synergistic benefits of E2 gel and exercise, which are currently unknown.