Mifepristone (RU-486) in Androgen Independent Prostate Cancer
A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins
1 other identifier
interventional
48
1 country
4
Brief Summary
The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.
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 Feb 2005
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedDecember 9, 2009
December 1, 2009
1.3 years
August 30, 2005
December 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer
2 years
Secondary Outcomes (1)
To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer
Interventions
Eligibility Criteria
You may qualify if:
- Histologic documentation of adenocarcinoma of the prostate
- Bone metastasis(es) by bone scan or cat scan
- Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
- One prior chemotherapy treatment is allowed.
- \> 3 weeks since major surgery
- \> 4 weeks since radiotherapy
- \> 8 weeks since prior strontium-89 or samarium 153
- ECOG performance status 0 or 1
- Absolute neutrophil count (ANC) \> 1,500/ul
- Platelets \> 100,000/ul
- Bilirubin \< 1.5 x upper limit of normal (ULN)
- AST or ALT \< 3 x ULN
- Creatinine \< 1.5 x ULN
- Electrolytes within 10% of normal range
- Serum testosterone \< 50ng/dL
- +1 more criteria
You may not qualify if:
- Concomitant therapy with corticosteroids
- Chemotherapy within 28 days
- Currently active second malignancy other than non-melanoma skin cancer
- Baseline adrenal insufficiency requiring long-term steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Beth Israel Deaconess Medical Centercollaborator
- Massachusetts General Hospitalcollaborator
- Brigham and Women's Hospitalcollaborator
- Georgetown Universitycollaborator
Study Sites (4)
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary-Ellen Taplin, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
February 1, 2005
Primary Completion
June 1, 2006
Study Completion
January 1, 2008
Last Updated
December 9, 2009
Record last verified: 2009-12