A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naive Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 07 Dec 2017
At a glance
- Drugs Radium 223 chloride (Primary) ; Abiraterone acetate; Prednisolone; Prednisone
- Indications Adenocarcinoma; Bone metastases; Prostate cancer
- Focus Registrational; Therapeutic Use
- Acronyms ERA223
- Sponsors Bayer
- 30 Nov 2017 According to a company media release, Bayer is unblinding this trial per the recommendation of an Independent Data Monitoring Committee (IDMC). The IDMC recommendation is due to the observation of an imbalance of more fractures and deaths in the treatment arm of this trial.
- 30 Nov 2017 According to a Bayer media release, an Independent Data Monitoring Committee (IDMC) has recommended to unblind this trial due to the observation of an imbalance of more fractures and deaths in the treatment arm.
- 06 Sep 2017 Planned primary completion date changed from 15 Dec 2017 to 15 May 2018.