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Prostate Cancer |
Drug: Ketoconazole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Assessing PSA Response in Low Dose Ketoconazole in Hormone Refractory Prostate Cancer Patients Who Have Failed at Least One Prior Systemic Chemotherapy Regimen |
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| Estimated Enrollment: | 30 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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| Experimental: Ketoconazole |
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Exclusion Criteria:
- Patients with any condition that impairs the ability to swallow medications orally
- Patients who are unable to give informed consent
- Patients who have received ketoconazole treatment for prostate cancer in the past
- Patients with other active malignancies in the past 3 years except nonmelanoma skin cancer
- Patients may not be receiving any other investigational agents
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| Study First Received: | May 6, 2009 |
| Last Updated: | June 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
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PSA Ketoconazole Prostate Cancer Hormone Refractory Chemotherapy Regimen |
Additional relevant MeSH terms:
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