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

Stanford University logo

Stanford University

Status and phase

Completed
Phase 1

Conditions

Prostate Cancer

Treatments

Drug: Oral Triamcinalone

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00186108
PROS0006

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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