Double-blind Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Metastases in Men With Hormone-refractory Prostate Cancer

Phase 1

• Conditions: Metastatic castrate-resistant prostate cancer; MedDRA version: 14.1Level: LLTClassification 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: EUCTR2006-000341-19-BE
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-19
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1904

Inclusion Criteria

-Men greater than or equal to 18 years of age with histologically-confirmed prostate cancer.
-Current or prior radiographic (ie, x-ray, computer tomography [CT], or magnetic resonance imaging [MRI]) evidence of at least 1 bone metastasis.
-Documented failure of at least one hormonal therapy as evidenced by a rising PSA (ie, 3 consecutive determinations, taken at least 2 weeks apart from one another. The third measurement must be greater than or equal to 0.4 ng/mL and taken within 8 weeks prior to randomization).
-Serum testosterone level of < 50 ng/dL due to either surgical or chemical castration
-Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
-Adequate organ function as defined by the following criteria:
1.Serum aspartate aminotransferase (AST) less than or equal to 5 x institutional upper limit of normal (ULN)
2. Serum alanine aminotransferase (ALT) less than or equal to 5 x ULN
3. Serum total bilirubin less than or equal to 2 x ULN
4. creatinine clearance (Cockcroft-Gault) greater than or equal to 30 mL/min
5. albumin-adjusted serum calcium greater than or equal to 2.0 mmol/L (8.0 mg/dL) and less than or equal to 2.9 mmol/L (11.5 mg/dL)
-Before any study-specific procedure is performed, 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 241
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1663

Exclusion Criteria

-Current or prior IV bisphosphonate administration for any reason
-Current or prior oral bisphosphonate administration for the treatment of bone metastases
-Planned radiation therapy or surgery to bone
-Prior administration of denosumab
-Known brain metastasis
-Life expectancy less than 6 months
-Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
-Active dental or jaw condition that requires oral surgery
-Non-healed dental/oral surgery
-Planned invasive dental procedure(s) for the course of the study
-Evidence of any of the following conditions per subject self report or medical chart review:
1. Known history of second malignancy within the past 3 years, except for basal cell carcinoma
2. Known infection with human immunodeficiency virus
3. Active infection with hepatitis B or hepatitis C virus
-Any 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 (ie, does not have marketing authorization) in another clinical trial
-Subject with reproductive potential who will not agree to use effective contraception (as defined by the investigator or designee)
-Known sensitivity to any of the products to be administered during dosing (eg, zoledronic acid, mammalian derived products, calcium or vitamin D)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified