NCT00667199

BAY88-8223, Does Response Study in HRPC Patients

A Double Blind, Dose Response Phase II, Multicentre Study of Radium 223 (Alpharadin®) for the Palliation of Painful Bone Metastases in Hormone Refractory Prostate Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of the investigational radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.

Detailed description

The study is designed to investigate whether there is a dose-response relationship for radium-223 in patients with painful bone metastases secondary to prostate carcinoma regarding palliation of bone pain. The palliative efficacy will be established through assessments of bone pain and consumption of analgesia. Furthermore, the aim is to find the most efficient dose with an acceptable safety profile. The safety will be assessed through measurements of adverse events, and acute haematological toxicity during the study period. Long-term chronic toxicity, and the overall survival at one and two years post treatment will also be assessed. This is a double-blind, dose-response, randomized, multi-centre phase II efficacy and safety study of radium- 223. The clinical sites will enroll a total of 100 eligible patients. The treatment is a single intravenous administration of radium-223. The target population is patients suffering from bone pain due to skeletal metastasis secondary to hormone refractory prostate cancer.

Conditions

• Hormone Refractory Prostate Cancer
• Bone Metastases

Interventions

Type	Name	Description
DRUG	Radium-223 dichloride (BAY88-8223)	The required volume of study drug to be administered to a patient was calculated using the patient's body weight, the dose (5 , 25 , 50 or 100 kBq/kg b.w.)

Timeline

• Start date: 2005-05-30
• Primary completion: 2008-04-01
• Completion: 2009-10-06
• First posted: 2008-04-28
• Last updated: 2023-04-19