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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-09-30

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oral Triamcinalone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Sandy Srinivas, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University Cancer Center

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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PROS0006

Identifier Type: -

Identifier Source: org_study_id