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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186108
• Other study ID #: PROS0006
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: July 24, 2007
• Start date: October 2002
• Est. completion date: September 2005

Study information

• Verified date: July 2007
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Oral Triamcinalone

Locations

Country	Name	City	State
United States	Stanford University Cancer Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response.		Following treatment
Secondary	Safety and tolerability at this dose and schedule, time to sustained biochemical response, duration of biochemical response, time to disease progression		Following treatment