check_circleStudy Completed

Prostate Cancer, Neoplasm Metastasis

A Placebo-controlled Phase II Study of Bone-targeted Radium-223 in Symptomatic Hormone-refractory Prostate Cancer

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

40 - N/A

Trial summary

Enrollment Goal
64
Trial Dates
February 2004 - May 2007
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
Linköping University HospitalLinköping, Sweden
Completed
Länssjukhuset Sundsvall-HärnösandSundsvall, Sweden
Completed
Nottingham City HospitalNottingham, United Kingdom

Primary Outcome

  • Time to occurrence of Skeletal-related Events (SRE)
    SREs are defined as: Increase in pain severity index during the last week; Increase in analgesic consumption; Neurological symptoms secondary to skeletal manifestations of prostate cancer; New pathologic bone fractures (vertebral and non-vertebral); Tumour related orthopaedic surgical intervention; Subsequent external beam radiation to relieve skeletal pain; Use of radioisotopes to relieve new skeletal related symptoms; Use of corticosteroids for skeletal pain, at doses aimed for pain palliation; Use of chemotherapy, bisphosphonates, or hormones, for the treatment of skeletal disease progression
    date_rangeTime Frame:
    Up to 12 Month
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    Safety Issue:
    No
  • Relative change (%) in bone-ALP levels from baseline to 4 weeks after last injection
    date_rangeTime Frame:
    Up to 12 Month
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    Safety Issue:
    No

Secondary Outcome

  • Number of SREs per patient
    date_rangeTime Frame:
    Up to 12 Month
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    Safety Issue:
    No
  • Changes in the levels of biochemical markers of bone formation
    date_rangeTime Frame:
    Up to 12 Month
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    Safety Issue:
    No
  • Change in Prostate Specific Antigen (PSA)
    date_rangeTime Frame:
    Up to 12 Month
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    Safety Issue:
    No
  • Change in pain level
    date_rangeTime Frame:
    Up to 12 Month
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    Safety Issue:
    No
  • Changes in analgesic use during study period
    date_rangeTime Frame:
    Up to 12 Month
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    Safety Issue:
    No
  • Changes in Edmonton Symptom Assessment Scale (ESAS) from baseline
    date_rangeTime Frame:
    Up to 12 Month
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    Safety Issue:
    No
  • Overall survival
    date_rangeTime Frame:
    up to 24 months
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    Safety Issue:
    Yes
  • Adverse events
    date_rangeTime Frame:
    up to 24 months
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    Safety Issue:
    Yes
  • Clinical laboratory tests including haematology, renal and liver function parameters
    date_rangeTime Frame:
    up to 24 months
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    Safety Issue:
    Yes

Trial design

A Phase II Randomised, Placebo-controlled, Multicentre Study in Prostate Cancer Patients With Painful Bone Metastases to Evaluate the Efficacy of Repeated Radium-223 Injections
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2