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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

Resource links provided by NLM:

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Primary Outcome Measures:

Secondary Outcome Measures:

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 Drug: 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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  • Patients must be >18 years old
  • Patients must have received at least one prior chemotherapy regimen >3 weeks prior to initiation of study and patients must have recovered from the side effects of the therapy
  • Patients must have an ECOG status of 0-3

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  • Patients must have a serum total testosterone level <50 ng/dl

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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
  • Patients with known hypersensitivity to ketoconazole

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Investigators
Principal Investigator:

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No publications provided

Responsible Party:

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Other Study ID Numbers:

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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:
Prostatic Neoplasms

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Prostatic Diseases
Hormones
Ketoconazole

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