#Radium injections for prostate cancer trial#

Place, publisher, year, edition, pagesElsevier, 2018. Conclusions: Final long-term safety ALSYMPCA analysis shows that radium-223 remained well tolerated, with low myelosuppression incidence and no new safety concerns. Limitations include short (3-yr) follow-up. One radium-223 patient had aplastic anemia 16 mo after the last injection. Long-term follow-up showed no AML, MDS, or new primary bone cancer secondary non-treatment-related malignancies occurred in four radium-223 and three placebo patients. Ninety-eight of 600 (16%) radium-223 and 68/301 (23%) placebo patients experienced grade 5 TEAEs. Grade 3/4 hematologic TEAEs in radium-223 and placebo groups were anemia (13% vs 13%), neutropenia (2% vs 1%), and thrombocytopenia (7% vs 2%). Results and limitations: During treatment to 12 wk following the last injection, 564/600 (94%) radium-223 and 292/301 (97%) placebo patients had treatment-emergent AEs (TEAEs). arm and the Radium will be given to you by a slow injection. Data analysis used descriptive statistics. Some men with prostate cancer may develop bone metastases. Additional long-term safety was assessed by development of acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), aplastic anemia, and secondary malignancies. Outcome measurements and statistical analysis: All adverse events (AEs) were collected until 12 wk after the last injection subsequently, only treatment-related AEs were collected. Forty-eight of 405 (12%) radium-223 and 12/167 (7%) placebo patients completed follow-up, with evaluations every 2 mo for 6 mo, then every 4 mo until 3 yr. Patients (405 radium-223 and 167 placebo) entered long-term safety follow-up starting 12 wk after the last study-drug injection, to 3 yr from the first injection.

#Radium injections for prostate cancer trial#

Design, setting, and participants: Safety analyses from phase 3 randomized ALSYMPCA trial included patients receiving >= 1 study-drug injection (600 radium-223 and 301 placebo). Objective: To report updated ALSYMPCA safety, including long-term safety up to 3 yr after the first injection. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benefit assessment. 427-435 Article in journal (Refereed) Published Abstract īackground: In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Show others and affiliations 2018 (English) In: European Urology, ISSN 0302-2838, E-ISSN 1873-7560, Vol.