Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer
- Conditions
- Castrate-resistant prostate cancerMedDRA version: 14.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-005485-37-FI
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1435
Men with histologically confirmed prostate cancer
-Age = 18 years
-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-Chemical or surgical castration defined as:
• bilateral orchiectomy (also referred to as orchidectomy) at least 6 months before randomization, OR
• continuous androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) agonist or antagonist for at least 6 months before randomisation
-Total serum testosterone level of < 50 ng/dL (1.72 nmol/L)
-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 = 1.0 ng/mL
-High risk for development of bone metastasis defined as:
• PSA value = 8.0 ng/mL, obtained no more than 3 months before randomisation
OR
• PSA doubling time = 10.0 months
-Adequate organ function as defined by the following criteria:
• Serum aspartate aminotransferase (AST) = 2.5 x upper limit of normal (ULN)
• Serum alanine aminotransferase (ALT) = 2.5 x ULN
• Serum total bilirubin = 1.5 x ULN
• Serum calcium or albumin-adjusted serum calcium = 2.0 mmol/L (8.0 mg/dL) and = 2.9 mmol/L (11.5 mg/dL)
-Before any study-specific procedure, the appropriate written informed consent must be obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 236
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1199
-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
-Prior or current use of oral bisphosphonates as follows:
• Greater than or equal to 3 years continuously
• Greater than 3 months but less than 3 years (eligible if subject has a 1 year washout before randomisation)
-Prior administration of AMG 162
-Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw
-Evidence of any of the following conditions per subject self report or medical chart review:
• Any prior malignancy (other than treated basal cell skin cancer), within 5 years before randomization
• Major surgery or significant traumatic injury occurring within 4 weeks before randomisation
• Active infection with Hepatitis B virus or Hepatitis C virus
• Known infection with human immunodeficiency virus (HIV)
-Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
-Thirty days or less since receiving an investigational product or device in another clinical trial.
-Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.;Secondary Objective: To compare the treatment effect of denosumab with placebo on:<br>• time to first bone metastasis excluding deaths<br>• overall survival<br><br>To assess the safety and tolerability of denosumab compared with placebo.;Primary end point(s): Bone metastasis-free survival determined by the time to first occurrence of bone metastasis (either symptomatic or asymptomatic) or death from any cause;Timepoint(s) of evaluation of this end point: Primary analysis cut-off date is event-driven (i.e. when approximately 660 subjects have developped bone metastasis or died)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Time to first bone metastasis (either symptomatic or asymptomatic) excluding death <br>• Overall survival time<br>• Subject incidence of treatment-emergent adverse events<br>• Changes in laboratory values<br>• Subject incidence of anti-denosumab neutralizing antibody formation;Timepoint(s) of evaluation of this end point: Analysis cut-off date is event-driven (i.e. when approximately 660 subjects have developped bone metastasis or died)