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Ketoconazole and Dexamethasone in Prostate Cancer (Keto/Dex)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01036594
Recruitment Status : Unknown
Verified September 2017 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : December 21, 2009
Last Update Posted : September 18, 2017
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This is an open label, phase II, single center trial of ketoconazole/dexamethasone to determine if the administration of ketoconazole/dexamethasone, after disease progression with ketoconazole/hydrocortisone slows or reverses disease progression in men with progressive prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ketoconazole, hydrocortisone Drug: Ketoconazole, dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Endocrinologically and Pharmacologically Directed Trial of Ketoconazole and Corticosteroids in Castration Resistant Prostate Cancer
Actual Study Start Date : December 11, 2009
Actual Primary Completion Date : December 11, 2012
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: Ketoconazole, Hydrocortisone Drug: Ketoconazole, hydrocortisone
Ketoconazole 400mg po tid Hydrocortisone 20mg po qam and 10mg po qpm

Experimental: Ketoconazole, dexamethasone Drug: Ketoconazole, dexamethasone
Ketoconazole 400md po tid Dexamethasone 1mg po bid

Primary Outcome Measures :
  1. To evaluate the proportion of patients who have achieved a response to ketoconazole with hydrocortisone and then, following progression achieved a second >30% decline in PSA upon receiving dexamethasone along with ketoconazole. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate.
  • Testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
  • Progressive non-metastatic or metastatic disease after androgen deprivation. Patients must have EITHER:

    1. Progression as defined by RECIST criteria. OR
    2. Progressive PSA documented within 4 weeks of enrollment. PSA evidence for progressive prostate cancer consists of a PSA level of at least 5 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart. If the confirmatory PSA value is less than the first documented rising PSA value, then an additional test for rising PSA will be required to document progression.
  • Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen.

    1. Disease progression after antiandrogen withdrawal is defined as 2 consecutive rising PSA values, obtained at least 2 weeks apart, or documented osseous or soft tissue progression.
    2. For patients receiving flutamide, at least one of the PSA values must be obtained 4 weeks or more after flutamide discontinuation.
    3. For patients receiving bicalutamide (Casodex) or nilutamide, at least one of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation.
  • Karnofsky Performance Status ≥ 60%.
  • Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment.
  • Patients on stable doses of bisphosphonates may continue on this medication; further, patients may initiate bisphosphonate therapy at the time of ketoconazole initiation.
  • Prior radiation therapy completed ≥ 4 weeks prior to enrollment.
  • Liver function tests (ALT, AST, and Bilirubin) must be within normal limits.
  • ANC >1500/µl, Platelet count > 100,00/µl, Creatinine <1.5 x upper limit of normal (ULN), Hemoglobin > 8 mg/dl.

Exclusion Criteria:

  • Prior chemotherapy for prostate cancer is not allowed with the exception of cases in which chemotherapy has been administered in a neoadjuvant or adjuvant fashion AND >1 year has elapsed since the administration of this therapy.
  • No prior ketoconazole, abiraterone, aminoglutethimide or corticosteroids for treatment of progressive prostate cancer.
  • No supplements or complementary medicines/botanicals are permitted while on protocol therapy, except for any combination of the following: (conventional multivitamin supplements, selenium, lycopene, soy supplements) No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
  • No "currently active" second malignancy, other than non-melanoma skin cancer.
  • No serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled.
  • No psychiatric illnesses/social situations that would limit compliance
  • No active or uncontrolled autoimmune disease.
  • No adrenal insufficiency as demonstrated by a baseline ACTH stimulation test demonstrating a peak cortisol >18 µg/dL.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01036594

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Charles J. Ryan, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco Identifier: NCT01036594    
Other Study ID Numbers: CC # 09553
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Keywords provided by University of California, San Francisco:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
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
Molecular Mechanisms of Pharmacological Action
Antifungal Agents