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A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00186108
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 25, 2007
Sponsor:
Collaborator:
United States Department of Defense
Information provided by:
Stanford University

Study Description
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Brief Summary:
The primary purpose of this study is to evaluate the ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. Secondary goals are to describe the safety and tolerability at this dose and schedule, to determine the time to sustained biochemical response, to determine the duration of biochemical response, to determine the time to disease progression.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Oral Triamcinalone Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer
Study Start Date : October 2002
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. [ Time Frame: Following treatment ]

Secondary Outcome Measures :
  1. Safety and tolerability at this dose and schedule, time to sustained biochemical response, duration of biochemical response, time to disease progression [ Time Frame: Following treatment ]

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • 18 years of age and older
  • Histologically documented adenocarcinoma of prostate
  • Currently receiving LHRH agonists with castrate levels of testosterone or who have had an orchiectomy
  • Must have had a rise in PSA despite anti androgen withdrawal
  • Exhibit 2 consecutive rise in PSA after the last hormonal manipulation
  • Minimum PSA of greater than 5 KPS greater than 80%
  • Normal cortisol level at entry
  • Life expectancy greater than 6 months
  • Provide written consent pursuant to regulatory requirements prior to initiation of study procedure

Exclusion criteria:

  • Younger than 18 years
  • Patients without prostate cancer
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00186108


Locations
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United States, California
Stanford University Cancer Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
United States Department of Defense
Investigators
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Principal Investigator: Sandy Srinivas, MD Stanford University
More Information
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ClinicalTrials.gov Identifier: NCT00186108    
Other Study ID Numbers: PROS0006
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: July 2007
Keywords provided by Stanford University:
Oral Triamcinalone
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases