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

Stanford University

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: Oral Triamcinalone

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00186108

PROS0006

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)