Ketoconazole and Dexamethasone in Prostate Cancer (Keto/Dex)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: December 17, 2009
Last updated: October 2, 2015
Last verified: October 2015
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 Intervention Phase
Prostate Cancer
Drug: Ketoconazole, hydrocortisone
Drug: Ketoconazole, dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Endocrinologically and Pharmacologically Directed Trial of Ketoconazole and Corticosteroids in Castration Resistant Prostate Cancer

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: December 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders 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.
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Please refer to this study by its identifier: NCT01036594

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

Responsible Party: University of California, San Francisco Identifier: NCT01036594     History of Changes
Other Study ID Numbers: CC # 09553 
Study First Received: December 17, 2009
Last Updated: October 2, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Neoplasms by Site
Urogenital Neoplasms
Hydrocortisone 17-butyrate 21-propionate
Genital Diseases, Male
Prostatic Diseases
BB 1101
Cortisol succinate
Dexamethasone 21-phosphate
Dexamethasone acetate
Hydrocortisone acetate
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Anti-Inflammatory Agents
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids processed this record on April 27, 2016