Trimodal treatment for localized high risk prostate cancer A design of a phase II, multi-center, open-label, randomized, parallel-group study to compare the effectiveness and safety of radical prostatectomy, external beam radiotherapy (EBRT) and androgen deprivation therapy (ADT) versus EBRT and ADT for patients with localized high risk prostate cancer.

Abstract

Background: Prostate cancer is the second most prevalent neoplasm in men worldwide and the first leading cause of death around the globe. High-risk prostate cancer represents 15% of all prostate cancer patients and, by definition, multimodal treatments are encouraged in order to achieve control of the disease, and even potential cure. Available treatments for such patients have been compared and there is no definitive evidence related to the superiority between surgery (radical prostatectomy – RP) and radiation therapy with or without hormone therapy. Aims: To compare two multimodal treatment of high-risk prostate cancer: radical prostatectomy associate to adjuvant external radiation therapy and androgen deprivation therapy versus external radiation therapy plus androgen deprivation therapy .This study will analyze the following outcomes: time to PSA recurrence, metastasis free survival, defined as time to first clinical or radiological progression or death from any cause; overall survival, adverse events according to graduation of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (17) and, quality of life assessed by Expanded Prostate Cancer Index Composite (EPIC) questionnaire life. Methods: This is a proposed design and protocol for a phase II, prospective, randomized, open-label, and multicenter trial, including a total of 322 patients with localized high-risk prostate cancer. Potential impact of the study: At the best of our knowledge, there aren’t any randomized controlled trials to analyze the trimodal treatment. The possible outcomes of this study will offer a better evidence to high-risk prostate cancer and its results will change the standard treatment in this set of patients by reducing significantly local recurrence and offering a potential cure for this malady. Keywords: Prostatic neoplasm , Combined Modality Therapy, prostatectomy, radiotherapy, Androgen Antagonists