Ketoconazole and Dexamethasone in Prostate Cancer (Keto/Dex)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01036594
First received: December 17, 2009
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036594

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01036594     History of Changes
Other Study ID Numbers: CC # 09553
Study First Received: December 17, 2009
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Ketoconazole
Dexamethasone

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexamethasone acetate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Dexamethasone
Hydrocortisone
Dexamethasone 21-phosphate
BB 1101
Ketoconazole
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on July 22, 2014