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Last verified: June 2012

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Purpose

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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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Primary Outcome Measures:

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Secondary 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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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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Contacts and Locations

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Contacts

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Locations

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Recruiting

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Sponsors and Collaborators

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Investigators

Principal Investigator:

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More Information

No publications provided

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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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Urogenital Neoplasms
Neoplasms by Site
Neoplasms

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Prostatic Diseases
Hormones
Ketoconazole

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Physiological Effects of Drugs
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Therapeutic kenmore de luxe 117552 manuals

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