Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006044
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2000-07-05
Brief Title:
Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Trial of Testosterone in Patients With Progressive Androgen-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE High doses of testosterone may be effective in killing prostate cancer cells that no longer respond to hormone therapy
PURPOSE Phase I trial to study the effectiveness of testosterone in treating patients who have progressive prostate cancer that no longer responds to hormone therapy
PURPOSE Phase I trial to study the effectiveness of testosterone in treating patients who have progressive prostate cancer that no longer responds to hormone therapy
Detailed Description:
OBJECTIVES
Determine the safety and maximum tolerated dose of exogenously administered testosterone in patients with progressive androgen-independent prostate cancer who have been in castrate state either surgically or pharmacologically for a minimum of 1 year
Assess the changes in expression of androgen receptor and other receptors in human biopsy specimens or circulating tumor cells before and after this treatment in this patient population
OUTLINE This is a dose-escalation study
Patients receive testosterone via an enhanced absorption transdermal system continuously for 28 days The transdermal patches are changed daily
Cohorts of 3-6 patients receive a fixed daily dose of testosterone with escalating duration of exposure until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities
Patients are followed at day 1 and at weeks 2 and 4
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study
Determine the safety and maximum tolerated dose of exogenously administered testosterone in patients with progressive androgen-independent prostate cancer who have been in castrate state either surgically or pharmacologically for a minimum of 1 year
Assess the changes in expression of androgen receptor and other receptors in human biopsy specimens or circulating tumor cells before and after this treatment in this patient population
OUTLINE This is a dose-escalation study
Patients receive testosterone via an enhanced absorption transdermal system continuously for 28 days The transdermal patches are changed daily
Cohorts of 3-6 patients receive a fixed daily dose of testosterone with escalating duration of exposure until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities
Patients are followed at day 1 and at weeks 2 and 4
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1818 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA005826 |
| P30CA008748 | NIH | None | None |
| P01CA005826 | NIH | None | None |
| MSKCC-99115 | None | None | None |