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

Stanford University23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Oral TriamcinaloneDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University Cancer Center

Stanford, California, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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