check_circleStudy Completed

Prostate Cancer, Neoplasm Metastasis

BAY88-8223, dose finding study in pts with HRPC

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 Years

Trial summary

Enrollment Goal
122
Trial Dates
May 2006 - December 2009
Phase
Phase 2
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
The Royal Marsden HospitalSutton, SM2 5RT, United Kingdom

Primary Outcome

  • Proportion of participants in each dose group with a confirmed PSA response
    PSA response; each patient will be classified as PSA responder/non-responder according to the definition of PSA response:a decrease from baseline of at least 50% maintained for at least three weeks.
    date_rangeTime Frame:
    24 weeks, 12 months, 24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • The maximum percent decrease in PSA level compared to baseline
    date_rangeTime Frame:
    24 weeks, 12 months, 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to PSA Progression
    date_rangeTime Frame:
    24 weeks, 12 months, 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Bone-ALP response (classified as for PSA response) and decrease in bone-ALP level compared to baseline
    date_rangeTime Frame:
    24 weeks, 12 months, 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Total number of SRE per patient
    date_rangeTime Frame:
    24 weeks, 12 months, 24months
    enhanced_encryption
    Safety Issue:
    No
  • Pain Assessment and analgesic consumption
    date_rangeTime Frame:
    24 weeks, 12 months, 24months
    enhanced_encryption
    Safety Issue:
    No
  • Time to death from first treatment
    date_rangeTime Frame:
    24 weeks, 12 months, 24months
    enhanced_encryption
    Safety Issue:
    No
  • Time to Skeletal Related Events (SRE)
    date_rangeTime Frame:
    24 weeks, 12 months, 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Adverse events, blood chemistry and haematological toxicity
    date_rangeTime Frame:
    24 weeks, 12 months, 24 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A double blind, randomised, dose finding, repeat dose, phase II, multicentre study of Alpharadin® for the treatment of patients with hormone refractory prostate cancer and skeletal metastases
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3