Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study
2007 (English)In: The Lancet Oncology, ISSN 1470-2045, E-ISSN 1474-5488, Vol. 8, no 7, 587-594 p.Article in journal (Refereed) Published
Background: The alpha-emitter radium-223 (223Ra) is a bone-seeking radionuclide studied as a new treatment for patients with bone metastases from hormone-refractory prostate cancer. We aimed to study mature outcomes from a randomised, multicentre, phase II study of 223Ra. Methods: Patients with hormone-refractory prostate cancer and bone pain needing external-beam radiotherapy were assigned to four intravenous injections of 223Ra (50 kBq/kg, 33 patients) or placebo (31 patients), given every 4 weeks. Primary endpoints were change in bone-alkaline phosphatase (ALP) concentration and time to skeletal-related events (SREs). Secondary endpoints included toxic effects, time to prostate-specific-antigen (PSA) progression, and overall survival. All tests were done at a 5% significance level, based on intention to treat. Findings: Median relative change in bone-ALP during treatment was -65·6% (95% CI -69·5 to -57·7) and 9·3% (3·8-60·9) in the 223Ra group and placebo groups, respectively (p
Place, publisher, year, edition, pages
2007. Vol. 8, no 7, 587-594 p.
IdentifiersURN: urn:nbn:se:liu:diva-49310DOI: 10.1016/S1470-2045(07)70147-XOAI: oai:DiVA.org:liu-49310DiVA: diva2:270206