Back to resultsA Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oral Triamcinalone
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Oral Triamcinalone, Prostate Cancer
Eligibility 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
Sites / Locations
- Stanford University Cancer Center
Outcomes
Primary Outcome Measures
Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response.
Secondary Outcome Measures
Safety and tolerability at this dose and schedule, time to sustained biochemical response, duration of biochemical response, time to disease progression
Full Information
NCT ID
NCT00186108
First Posted
September 13, 2005
Last Updated
July 24, 2007
Sponsor
Stanford University
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT00186108
Brief Title
A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer
Official Title
A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
Collaborators
United States Department of Defense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Oral Triamcinalone, Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oral Triamcinalone
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandy Srinivas, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer
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