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A phase II randomized trial of RAdium-223 dichloride and SABR Versus SABR for oligomEtastatic prostate caNcerS (RAVENS)

Authors :
Hamza Hasan
Matthew P. Deek
Ryan Phillips
Robert F. Hobbs
Reem Malek
Noura Radwan
Ana P. Kiess
Shirl Dipasquale
James Huang
Terry Caldwell
Jessica Leitzel
Danielle Wendler
Hao Wang
Elizabeth Thompson
Jonathan Powell
Sara Dudley
Curtiland Deville
Stephen C. Greco
Daniel Y. Song
Theodore L. DeWeese
Michael A. Gorin
Steven P. Rowe
Sam Denmeade
Mark Markowski
Emmanuel S. Antonarakis
Michael A. Carducci
Mario A. Eisenberger
Martin G. Pomper
Kenneth J. Pienta
Channing J. Paller
Phuoc T. Tran
Source :
BMC Cancer, Vol 20, Iss 1, Pp 1-13 (2020)
Publication Year :
2020
Publisher :
BMC, 2020.

Abstract

Abstract Background Metastasis directed therapy (MDT) for patients with oligometastatic disease is associated with improvements in progression free survival (PFS) and overall survival (OS) compared to systemic therapy alone. Additionally, within a prostate-cancer-specific cohort, MDT is able to forestall initiation of androgen deprivation therapy (ADT) in men with hormone-sensitive, oligometastatic prostate cancer (HSOPCa) compared to observation. While MDT appears to be safe and effective in HSOPCa, a large percentage of men will eventually have disease recurrence. Patterns of failure in HSOPCa demonstrate patients tend to have recurrence in the bone following MDT, raising the question of sub-clinically-apparent osseous disease. Radium-223 dichloride is a radiopharmaceutical with structural similarity to calcium, allowing it to be taken up by bone where it emits alpha particles, and therefore might have utility in the treatment of micrometastatic osseous disease. Therefore, the primary goal of the phase II RAVENS trial is to evaluate the efficacy of MDT + radium-223 dichloride in prolonging progression free survival in men with HSOPCa. Methods Patients with HSOPCa and 3 or less metastases with at least 1 bone metastasis will be randomized 1:1 to stereotactic ablative radiation (SABR, also known as stereotactic body radiation therapy (SBRT)) alone vs SABR + radium-223 dichloride with a minimization algorithm to balance assignment by institution, primary intervention, prior hormonal therapy, and PSA doubling time. SABR is delivered in one to five fractions and patients in the SABR + radium-223 dichloride arm will receive six infusions of radium-223 dichloride at four-week intervals. The primary end point is progression free survival. The secondary clinical endpoints include toxicity and quality of life assessments, local control at 12 months, locoregional progression, time to distant progression, time to new metastasis, and duration of response. Discussion The RAVENS trial will be the first described phase II, non-blinded, randomized study to compare SABR +/− radium-223 dichloride in patients with HSOPCa and 3 or less metastases with at least one bone metastasis. The primary hypothesis is that SABR + radium-223 dichloride will increase median progression-free survival from 10 months in the SABR arm to 20 months in the SABR + radium-223 dichloride arm. Trial registrations Clinicaltrials.gov. Identifier: NCT04037358 . Date of Registration: July 30, 2019. Date of First Participant Enrolled: August 9, 2019. Date of Last Approved Amendment: October 16, 2019. Protocol Version: Version 5.

Details

Language :
English
ISSN :
14712407
Volume :
20
Issue :
1
Database :
Directory of Open Access Journals
Journal :
BMC Cancer
Publication Type :
Academic Journal
Accession number :
edsdoj.7f8bbe93b0463988e5fcc8db1a4287
Document Type :
article
Full Text :
https://doi.org/10.1186/s12885-020-07000-2