Expired Study
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Stanford, California 94305


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.


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


Study is Available At:


Original ID:

PROS0006


NCT ID:

NCT00186108


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

23


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sandy Srinivas, MD
Principal Investigator
Stanford University

Study Dates

Start Date:October 2002
Completion Date:September 2005
Completion Type:Actual
Verification Date:July 2007
Last Changed Date:July 24, 2007
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Oral Triamcinalone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Department of Defense

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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