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


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Following treatment

Principal Investigator

Sandy Srinivas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

PROS0006

NCT ID:

NCT00186108

Start Date:

October 2002

Completion Date:

September 2005

Related Keywords:

  • Prostate Cancer
  • Oral Triamcinalone
  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Stanford University Cancer CenterStanford, California  94305