Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer

NCT00286091 | Completed Phase 3 Results DMC

• 1 other identifier: 20050147
• Study Type: interventional
• Target: 1,435
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is 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.

Conditions

Hormone Refractory Prostate Cancer

Keywords

Hormone refractory prostate cancer; androgen independent; ADT; bone metastasis

Outcome Measures

Primary Outcomes (1)

• Bone Metastasis-free Survival

  The time to the first occurrence of bone metastasis (either symptomatic or asymptomatic) or death from any cause. Participants who did not experience bone metastasis or on-study death were censored at the last on-study contact date or the primary analysis data cutoff date, whichever came first. Median bone metastasis-free survival time was estimated using the Kaplan-Meier method.

  From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.

Secondary Outcomes (2)

• Time to First Bone Metastasis

  From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.

• Overall Survival

  From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received placebo subcutaneous injections every 4 weeks during the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injection every 4 weeks during the open-label extension phase.

Biological: Placebo

Denosumb

EXPERIMENTAL

Participants received 120 mg denosumab administered by subcutaneous injection every 4 weeks during the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injection every 4 weeks during the open-label extension phase.

Biological: Denosumab

Interventions

Denosumab BIOLOGICAL

Administered by subcutaneous injection

Also known as: XGEVA®

Denosumb

Placebo BIOLOGICAL

Same volume subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men with histologically confirmed prostate cancer
• bilateral orchiectomy 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 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 prostate-specific antigen (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

You may not qualify if:

• 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 intravenous bisphosphonate administration

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Smith MR, Saad F, Coleman R, Shore N, Fizazi K, Tombal B, Miller K, Sieber P, Karsh L, Damiao R, Tammela TL, Egerdie B, Van Poppel H, Chin J, Morote J, Gomez-Veiga F, Borkowski T, Ye Z, Kupic A, Dansey R, Goessl C. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet. 2012 Jan 7;379(9810):39-46. doi: 10.1016/S0140-6736(11)61226-9. Epub 2011 Nov 15.

  PMID: 22093187 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 3, 2006
• Study Start: January 24, 2006
• Primary Completion: July 30, 2010
• Study Completion: April 9, 2014
• Last Updated: October 17, 2018
• Results First Posted: April 6, 2015

Record last verified: 2018-09