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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Hormone Refractory Prostate Cancer

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Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer


Inclusion Criteria:



- men with histologically confirmed prostate cancer

- bilateral orchiectomy at least 6 months before randomization or continuous ADT with a
GnRH agonist or antagonist for at least 6 months before randomization

- total testosterone level less than 50 ng/dL,

- hormone refractory (androgen independent) prostate cancer demonstrated during
continuous ADT/post-orchiectomy defined as: 3 consecutive PSA values with PSA1 <
PSA2 < PSA3, each PSA value must be separated by at least 2 weeks, PSA2 and PSA3
greater than or equal to 1.0 ng/mL,

- high risk for development of bone metastasis defined as PSA value greater than or
equal to 8.0 ng/mL, obtained no more than 3 months before randomization OR PSA
doubling time less than or equal to 10.0 months

Exclusion Criteria:

- prior or current evidence of radiographically detectable bone metastasis

- known prior or current evidence of any metastatic involvement of distant organs
(lymph node metastases in any region is acceptable)

- prior or current IV bisphosphonate administration

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

subject incidence of treatment-emergent adverse events, immunogenicity, and safety laboratory parameters

Outcome Time Frame:

4 weeks after the last dose of open label treatment

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Australia: Therapeutic Goods Administration

Study ID:

20050147

NCT ID:

NCT00286091

Start Date:

February 2006

Completion Date:

February 2014

Related Keywords:

  • Hormone Refractory Prostate Cancer
  • Hormone refractory prostate cancer
  • androgen independent
  • ADT
  • bone metastasis
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

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