Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone
1 other identifier
interventional
44
1 country
2
Brief Summary
The main purpose of this study is to look at the effects (good or bad) that Atrasentan given alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction in men with prostate cancer that has spread to the bones.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 prostate-cancer
Started Dec 2001
Typical duration for phase_2 prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMay 10, 2010
May 1, 2010
5 years
September 9, 2005
May 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the effects of Atrasentan monotherapy with combination therapy using Atrasentan and Zometa on bone specific alkaline phosphatase.
Secondary Outcomes (1)
To evaluate the effects of Atrasentan monotherapy and combination therapy with Atrasentan and Zometa on PSA doubling time.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the prostate
- History of bilateral orchiectomy or current treatment with a GnRH agonist or antagonist
- Radiographically documented bone metastases
- Disease progression according to criteria from the PSA Working Group
You may not qualify if:
- Prior treatment with Atrasentan or Zometa within one year
- Serum creatinine \> 2.0mg/dL
- Documented cardiovascular disability status of New York Heart Association Class 2
- Treatment with chemotherapy, radiation, steroids, estrogens, or PC-SPES within 6 weeks
- Treatment with bisphosphonates or radiopharmaceuticals within 12 weeks
- History of Paget's disease, hyperthyroidism, hyperparathyroidism, Cushing's syndrome, hyperprolactinemia or other disorder associated with metabolic bone disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Dana-Farber Cancer Institutecollaborator
- Brigham and Women's Hospitalcollaborator
- Abbottcollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.
PMID: 33270906DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Smith, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
December 1, 2001
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
May 10, 2010
Record last verified: 2010-05