check_circleStudy Completed

Hormone Refractory Prostate Cancer, Bone Metastases

BAY88-8223, does response study in HRPC patients

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

40 Years

Trial summary

Enrollment Goal
100
Trial Dates
May 2005 - October 2009
Phase
Phase 2
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Primary Outcome

  • Pain Assessment (using a 100mm Visual Analogue Scale)
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Analgesic consumption
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Reduction of pain: the pain dimension of Quality of Life assessed using the Brief Pain Inventory (BPI) form, with total pain score and subtotals, after injection and compared to scores at baseline
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Duration of pain relief: measured as the time between the first and last evaluation time points at which the pain response criteria were met
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • The safety of radium-223: the total safety profile including adverse events and clinical laboratory measurements, with emphasis on haematological toxicity. Adverse events will be recorded continuously during the study period.
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    Yes
  • The date of death (if within 24 months after the injection of study drug)
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4