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The Oral Gonadotropin-releasing Hormone Receptor Antagonist Relugolix as Neoadjuvant/Adjuvant Androgen Deprivation Therapy to External Beam Radiotherapy in Patients with Localised Intermediate-risk Prostate Cancer: A Randomised, Open-label, Parallel-group Phase 2 Trial.

Title: The Oral Gonadotropin-releasing Hormone Receptor Antagonist Relugolix as Neoadjuvant/Adjuvant Androgen Deprivation Therapy to External Beam Radiotherapy in Patients with Localised Intermediate-risk Prostate Cancer: A Randomised, Open-label, Parallel-group Phase 2 Trial.
Authors: Dearnaley, DP; Saltzstein, DR; Sylvester, JE; Karsh, L; Mehlhaff, BA; Pieczonka, C; Bailen, JL; Shi, H; Ye, Z; Faessel, HM; Lin, H; Zhu, Y; Saad, F; MacLean, DB; Shore, ND
Contributors: Dearnaley, David
Publisher Information: ELSEVIER
Publication Year: 2020
Collection: The Institute of Cancer Research (ICR): Publications Repository
Description: BACKGROUND: External beam radiotherapy (EBRT) with neoadjuvant/adjuvant androgen deprivation therapy (ADT) is an established treatment option to prolong survival for patients with intermediate- and high-risk prostate cancer (PCa). Relugolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, was evaluated in this clinical setting in comparison with degarelix, an injectable GnRH antagonist. OBJECTIVE: To evaluate the safety and efficacy of relugolix to achieve and maintain castration. DESIGN, SETTING, AND PARTICIPANTS: A phase 2 open-label study was conducted in 103 intermediate-risk PCa patients undergoing primary EBRT and neoadjuvant/adjuvant ADT between June 2014 and December 2015. INTERVENTION: Patients randomly assigned (3:2) to 24-wk treatment with either daily oral relugolix or 4-wk subcutaneous depot degarelix (reference control). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the rate of effective castration (testosterone
Document Type: article in journal/newspaper
File Description: Print-Electronic; 192; application/pdf
Language: English
ISSN: 1873-7560; 0302-2838
Relation: European urology, 2020, 78 (2), pp. 184 - 192; https://repository.icr.ac.uk/handle/internal/3629
DOI: 10.1016/j.eururo.2020.03.001
Availability: https://doi.org/10.1016/j.eururo.2020.03.001; https://repository.icr.ac.uk/handle/internal/3629
Rights: https://creativecommons.org/licenses/by/4.0
Accession Number: edsbas.15CA2EF8
Database: BASE