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Completed

NCT Number: NCT00186108

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University Cancer Center

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Triamcinalone

Drug

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Jul 25, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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