NCT00186108

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

July 25, 2007

Status Verified

July 1, 2007

First QC Date

September 13, 2005

Last Update Submit

July 24, 2007

Conditions

Prostate Cancer

Keywords

Oral TriamcinaloneProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response.

    Following treatment

Secondary Outcomes (1)

  • Safety and tolerability at this dose and schedule, time to sustained biochemical response, duration of biochemical response, time to disease progression

    Following treatment

Interventions

Oral TriamcinaloneDRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Younger than 18 years
  • Patients without prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Cancer Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Sandy Srinivas, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

October 1, 2002

Study Completion

September 1, 2005

Last Updated

July 25, 2007

Record last verified: 2007-07

Locations

US(1)