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Trial record 30 of 117 for:    DUTASTERIDE

Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer (KHAD)

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ClinicalTrials.gov Identifier: NCT00673127
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : April 22, 2015
Last Update Posted : April 22, 2015
Sponsor:
Collaborators:
Massachusetts General Hospital
Dana-Farber Cancer Institute
Sunnybrook Health Sciences Centre
Oregon Health and Science University
M.D. Anderson Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Information provided by (Responsible Party):
Steven Balk, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE May 5, 2008
First Posted Date  ICMJE May 7, 2008
Results First Submitted Date  ICMJE July 9, 2013
Results First Posted Date  ICMJE April 22, 2015
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE February 2005
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
PSA Response [ Time Frame: From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months. ]
PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
To evaluate the efficacy of high dose ketoconazole and hydrocortisone in combination with dutasteride (KHAD) in the treatment of hormone refractory prostate cancer.
Change History Complete list of historical versions of study NCT00673127 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
Time to Progression [ Time Frame: Duration of time from treatment initiation until documented progression. Maximum 32 months ]
Duration of time from treatment initiation until documented progression (PSA or Disease progression)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
  • To evaluate the toxicity of the combination in hormone refractory prostate cancer. [ Time Frame: 2 years ]
  • To evaluate the time to progression on KHAD.
  • Correlate levels of androgens and metabolites with response.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Official Title  ICMJE A Phase II Trial of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Brief Summary The combination of ketaconazole and hydrocortisone is commonly used for the treatment of prostate cancer. The purpose of this study is to determine if the addition of a drug called dutasteride to this approved combination will make the combination more effective in treating prostate cancer.
Detailed Description
  • Participants will be seen by the study physician every four weeks and have a short physical examination, blood tests and be asked to provide information about their condition. Every three months they will undergo a bone scan. If the CT scan that was obtained before the participant started the study shows evidence of cancer, they will be asked to repeat this test every three months.
  • Ketaconazole will be taken orally three times a day on an empty stomach. Hydrocortisone will be taken orally in the morning and at night. Dutasteride will be taken orally once a day.
  • Participants may remain on study drug until there is evidence of disease progression.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: Ketoconazole, Hydrocortisone and Dutasteride

Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Pills should be taken with food or milk.

Dutasteride: 0.5mg orally once a day on an empty stomach or after eating a meal

Other Name: Dutasteride=Avodart
Study Arms  ICMJE Experimental: KHAD
Ketoconazole, Hydrocortisone and Dutasteride Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Dutasteride: 0.5 mg once a day
Intervention: Drug: Ketoconazole, Hydrocortisone and Dutasteride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2008)
57
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically documented evidence of prostate cancer (needle biopsy or prostatectomy). In the abscence of histologically documented evidence of prostate cancer, the diagnosis must be based on elevated serum PSA and metastatic lesions on bone scan.
  • Progressive HRPC defined as a PSA increase over baseline of >25% or 5ng/ml or new lesions on bone/CT scan after conventional androgen deprivation and antiandrogen withdrawal. Evidence of metastatic disease based on positive CT or bone scan is not required.
  • PSA of greater than or equal to 2ng/ml and serum total testosterone less than or equal to 50ng/ml
  • Prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy
  • Prior therapy with estrogens is permitted but must have been discontinued > 4 weeks prior to registration
  • ECOG Performance Status 0-2
  • Adequate renal function, hepatic function, and bone marrow function as outlined in protocol
  • ECG showing a normal QT interval

Exclusion Criteria:

  • Prior therapy with ketoconazole or corticosteroids for HRPC
  • Major surgery or radiation therapy within 4 weeks
  • Strontium-89 or samarium-153 therapy within 4 weeks
  • Thromboembolism in past 6 months
  • Patients who are taking drugs that may further prolong QT intervals and present a known risk for Torsades de Pointes.
  • Concomitant use of drugs known to be narrow therapeutic index CTP3A4
  • Drugs that are sensitive CYP3A4 substrates
  • Alcohol or drug dependence currently or in the last 6 months
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00673127
Other Study ID Numbers  ICMJE 04-414
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven Balk, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Sunnybrook Health Sciences Centre
  • Oregon Health and Science University
  • M.D. Anderson Cancer Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators  ICMJE
Principal Investigator: Steven Balk, MD Beth Israel Deaconess Medical Center
PRS Account Dana-Farber Cancer Institute
Verification Date April 2015

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