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Trial record 23 of 116 for:    cancer | butyrate

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

Tracking Information
First Submitted Date  ICMJE December 17, 2009
First Posted Date  ICMJE December 21, 2009
Last Update Posted Date September 18, 2017
Actual Study Start Date  ICMJE December 11, 2009
Actual Primary Completion Date December 11, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01036594 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Ketoconazole and Dexamethasone in Prostate Cancer
Official Title  ICMJE An Endocrinologically and Pharmacologically Directed Trial of Ketoconazole and Corticosteroids in Castration Resistant Prostate Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Ketoconazole, hydrocortisone
    Ketoconazole 400mg po tid Hydrocortisone 20mg po qam and 10mg po qpm
  • Drug: Ketoconazole, dexamethasone
    Ketoconazole 400md po tid Dexamethasone 1mg po bid
Study Arms  ICMJE
  • Experimental: Ketoconazole, Hydrocortisone
    Intervention: Drug: Ketoconazole, hydrocortisone
  • Experimental: Ketoconazole, dexamethasone
    Intervention: Drug: Ketoconazole, dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 18, 2009)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Actual Primary Completion Date December 11, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01036594
Other Study ID Numbers  ICMJE CC # 09553
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charles J. Ryan, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP