Prostate Cancer
Conditions
Keywords
Oral Triamcinalone, Prostate Cancer
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.
Interventions
DRUGOral Triamcinalone
Sponsors
United States Department of Defense
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. | Following treatment |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability at this dose and schedule, time to sustained biochemical response, duration of biochemical response, time to disease progression | Following treatment |
Countries
United States
Outcome results
None listed