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

This study has been completed.

Sponsors and Collaborators:	Stanford University Department of Defense
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00186108

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Oral Triamcinalone	Phase I

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title:	A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer

Further study details as provided by Stanford University:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Enrollment:	23
Study Start Date:	October 2002
Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186108

Locations

United States, California
Stanford University Cancer Center
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Department of Defense

Investigators

Principal Investigator:

Sandy Srinivas, MD

Stanford University

More Information

Study ID Numbers:	PROS0006
Study First Received:	September 13, 2005
Last Updated:	July 24, 2007
ClinicalTrials.gov Identifier:	NCT00186108
Health Authority:	United States: Institutional Review Board

Keywords provided by Stanford University:

Oral Triamcinalone
Prostate Cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009