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 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

Resource links provided by NLM:

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Primary Outcome Measures:

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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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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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  • Patients must have an ECOG status of 0-3

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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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Principal Investigator:

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PSA
Ketoconazole
Prostate Cancer
Hormone Refractory
Chemotherapy Regimen

Additional relevant MeSH terms:
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