A randomized, dose–response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer

Abstract

Pain response was seen in up to 71% of the patients with a dose response observed 2 weeks after administration. The highly tolerable side-effect profile of radium-223 previously reported was confirmed.

Patient-reported outcomes in metastatic castration-resistant prostate cancer

“…PROs have been included in more recent treatment trials but usually as secondary endpoints with the exception of the Phase II studies. 29,32,33 Several articles contained opaque, post-hoc exploratory analyses with little or no clear evidence that the patient reported endpoints chosen had been established a priori. Much of the published work was characterised by inappropriate choice of instruments, poor statistical analyses or scanty reporting and inadequate interpretation of results.…”

“…32 The effect of the treatment was documented by patients' self-assessment of pain using a VAS, the BPI and analgesia use. As is the case with many studies of patients with metastatic disease, few patients from the original sample survive for follow up; at 12 months data were available on 32/100 and 8/100 at 24 months.…”

A Phase 1, Open-Label Study of the Biodistribution, Pharmacokinetics, and Dosimetry of 223Ra-Dichloride in Patients with Hormone-Refractory Prostate Cancer and Skeletal Metastases

“…a-emitting radiopharmaceuticals are increasingly under evaluation and offer highly localized cytotoxic effects due to their short range and high linear energy transfer (6,7). 223 Ra-dichloride is a novel, bone-seeking a emitter that has been administered to approximately 900 patients with bone metastases from castrationresistant prostate cancer in phase I-III clinical trials worldwide (8)(9)(10)(11)(12)(13)(14). It has demonstrated an antitumor effect on bone metastases in animal models (15).…”

Targeted use of Alpha Particles: Current Status in Cancer Therapeutics

“…Both groups received external beam radiation therapy to painful areas. There were a statistically significant change in bone ALP and PSA response but not in time to SRE's and overall survival, as far as toxicity, the only significant difference includes more constipation in 223 Ra arm [62]. The above reported results warranted further evaluation of the product in a phase 3 trial.…”