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

Phase 1

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00186108
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study Completion: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-24
• Last Update Posted: 2007-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response.	Following treatment

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability at this dose and schedule, time to sustained biochemical response, duration of biochemical response, time to disease progression	Following treatment

Trial Locations

Locations (1)

Stanford University Cancer Center; 🇺🇸 Stanford, California, United States