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

This study has been completed.
Sponsor:
Collaborator:
Department of Defense
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186108
First received: September 13, 2005
Last updated: July 24, 2007
Last verified: July 2007
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Drug: Oral Triamcinalone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 23
Study Start Date: October 2002
Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186108

Locations
United States, California
Stanford University Cancer Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Department of Defense
Investigators
Principal Investigator: Sandy Srinivas, MD Stanford University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00186108     History of Changes
Other Study ID Numbers: PROS0006
Study First Received: September 13, 2005
Last Updated: July 24, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Oral Triamcinalone
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013