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.

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Published: May 21, 2020

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Roberto Paz-Manrique, MD
Dirección Científica y Académica, Oncosalud AUNA, Lima, Perú.
Lin I Ter, MD
Instituto Brasileiro de Controle de Câncer (IBCC Oncologia).
Ibrahim Alnadhari, MD
Urology department, AlWakra Hospital, Hamad Medical Corporation, Doha – Qatar.
Shahzad Qayyum, MBBS MRCP
West Hertfordshire NHS Trust, UK.
Nebal Abu Hussein, MD
Respiratory Medicine Department, University Hospital Bern, Inselspital, Bern-Switzerland.
Bárbara Vieira Carneiro, MD
Trauma and Emergency Surgery Intensive Care Unit - Hospital das Clínicas da Universidade de São Paulo - HCFMUSP - Brazil.
Carla Sakuma de Oliveira, MD MSc PhD
Medical School Coordinator. Universidade Estadual do Oeste do Paraná. Campus Cascavel/PR/Brazil.
Baha Eldin Osman Elhag, MBBS
Qatar Organ Donation Center - Hiba,HMC Doha Qatar.
Marina Martines da Costa, MBBS
State University of Londrina (UEL) – Brazil.
Renata Santos Bittencourt Silva, MD
Assistant doctor of Otolaryngology Department of Santa Casa de Misericórdia de São Paulo, Brazil.
Rodrigo J Montenegro Carrera, MD
Hidromed, Guatemala.
Marina Antunes Kasa, MBBS
Centro Universitário Lusíada (UNILUS) – Brazil.
Andy Alejandro Toribio Mejia, MD
Servicio Nacional De Salud, Universidad Católica Del Cibao, República Dominicana.
Rodrigo Silva de Paula Rocha, MD
GI Endoscopy Unit, Department of Gastroenterology, Hospital das Clinicas of the University of São Paulo Medical School, Sao Paulo, Brazil.
Mohammed Elamin Faris
Alumnus PPCR Class 2019
Abel Jesus Barragan Berlanga, MD
Escuela de Medicina del Tecnologico de Monterrey, Mexico.
Leonel Furtado Campos, MD
Surgical Intensive Care Unit, Anesthesiology Division, Hospital das Clínicas, University of São Paulo Medical School. HCFMUSP.
Hassan H Elamin
Alumnus PPCR Class 2019.
Francisca González Mc.Cawley, MD
Centro de Estudios Clinicos ICIM, Universidad del Desarrollo, Chile.
Stefan Szylewicz, MD
Neurosurgery Department, Uopeccan Cancer Hospital, Cascavel, Brazil.
Soraya Hijazi Vega, MD PhD
Physical Medicine and Rehabilitation. University Hospital Albacete. Spain.
Andrés Espinoza Briones, MD
Department of General, Visceral and Vascular Surgery, University Hospital Jena, Jena, Germany.
Giulio Bartié Rossi, MS
Faculdade de Medicina do ABC, Brazil.
Cristina Pires Camargo, MD PhD
Researcher Laboratório of Microsurgery and Plastic Surgery, Universidade de São Paulo, Brazil.

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

Article Details

How to Cite
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. (2020). Principles and Practice of Clinical Research, 6(1), 3-8. https://journal.ppcr.org/index.php/ppcrjournal/article/view/94
Issue
Vol. 6 No. 1 (2020): Principles and Practice of Clinical Research
Section
Clinical Research Design

How to Cite

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. (2020). Principles and Practice of Clinical Research, 6(1), 3-8. https://journal.ppcr.org/index.php/ppcrjournal/article/view/94

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