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

作者：Hamza Hasan, Matthew P. Deek, Ryan Phillips, Robert F. Hobbs, Reem Malek, Noura Radwan, Ana P. Kiess, Shirl Dipasquale, James Guoxian Huang, Terry G. Caldwell, Jessica Leitzel, Danielle Wendler, Hao Wang, Elizabeth A. Thompson, Jonathan D. Powell, S.A. Dudley, Curtiland Deville, Stephen Greco, Daniel Y. Song, Theodore L. DeWeese, Michael A. Gorin, Steven P. Rowe, S. Denmeade, Mark C. Markowski, Emmanuel S. Antonarakis, Michael A. Carducci, Mario A. Eisenberger, Martin G. Pomper, Kenneth J. Pienta, Channing J. Paller, Phuoc T. Tran · 发表于：BMC Cancer · 年份：2020 · DOI：10.1186/s12885-020-07000-2 · 被引用次数：33 · 研究领域：Prostate Cancer Treatment and Research、Bone health and treatments、Prostate Cancer Diagnosis and Treatment

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 ...