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Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

This study has been withdrawn prior to enrollment.
(Withdrawn due to low accrual)
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute Identifier:
First received: November 15, 2007
Last updated: January 31, 2013
Last verified: January 2013

RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving ketoconazole together with dexamethasone and hydrocortisone may help doctors learn more about how these drugs are used by the body.

PURPOSE: This randomized clinical trial is studying how ketoconazole, dexamethasone, and hydrocortisone act in the body of patients with prostate cancer that did not respond to androgen-deprivation therapy.

Condition Intervention
Prostate Cancer
Drug: dexamethasone
Drug: ketoconazole
Drug: therapeutic hydrocortisone
Procedure: pharmacological study

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Oral Ketoconazole on the Pharmacokinetics of Oral Dexamethasone and Oral Hydrocortisone in Patients With Androgen Independent Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Pharmacokinetics of oral dexamethasone with and without oral ketoconazole
  • Pharmacokinetics of oral hydrocortisone with and without oral ketoconazole

Enrollment: 0
Study Start Date: October 2007
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:


  • To evaluate the pharmacokinetics of oral dexamethasone with and without oral ketoconazole in patients with androgen-independent prostate cancer.
  • To compare the pharmacokinetics of oral hydrocortisone with and without oral ketoconazole in these patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral dexamethasone twice daily on days 1-14, oral ketoconazole 3 times daily on days 2-14 and 30-42, and oral hydrocortisone twice daily on days 29-42.
  • Arm II: Patients receive oral hydrocortisone twice daily on days 1-14, oral ketoconazole 3 times daily on days 2-14 and 30-42, and oral dexamethasone twice daily on days 29-42.

In both arms, patients may receive ketoconazole and hydrocortisone as standard salvage therapy off study.

In both arms, patients undergo blood sample collection on days 1, 14, 29, and 42 for pharmacokinetic studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Confirmed diagnosis of prostate cancer
  • Must have failed standard androgen-deprivation therapy

    • Evidence of rising PSA


  • ECOG performance status 0-2
  • Creatinine ≤ 2.0 mg/dL
  • AST and ALT < 4 times upper limit of normal
  • Bilirubin < 2.0 mg/dL
  • No active congestive heart failure
  • No allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole
  • No active infection
  • No uncontrolled glaucoma
  • No active peptic ulcer disease
  • No uncontrolled diabetes mellitus
  • Fertile patients must use effective contraception during and for 3 months after completion of study therapy


  • More than 2 weeks since prior and no concurrent drugs known to interact with study treatment
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Please refer to this study by its identifier: NCT00559481

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Donald L. Trump, MD Roswell Park Cancer Institute
  More Information Identifier: NCT00559481     History of Changes
Other Study ID Numbers: I 93506
Study First Received: November 15, 2007
Last Updated: January 31, 2013

Keywords provided by Roswell Park Cancer Institute:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017