Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003323
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
1999-11-01
Brief Title:
Hormone Therapy in Treating Patients With Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 Male hormones can stimulate the growth of prostate cancer cells Hormone therapy using flutamide and finasteride may fight prostate cancer by reducing the production of male hormones
PURPOSE Phase II trial to study the effectiveness of flutamide and finasteride in treating prostate cancer patients with high PSA levels who were previously treated with radiation therapy or radical prostatectomy
PURPOSE Phase II trial to study the effectiveness of flutamide and finasteride in treating prostate cancer patients with high PSA levels who were previously treated with radiation therapy or radical prostatectomy
Detailed Description:
OBJECTIVES
Determine the efficacy of finasteride and flutamide in suppressing prostate specific antigen PSA levels in patients with elevated PSA after definitive radiation therapy or radical prostatectomy for prostate cancer
Assess sexual function and other quality of life issues during this therapy
Estimate the response to flutamide withdrawal in this group of patients who have not had a major reduction in circulating testosterone levels
Measure the response rate to further hormonal manipulation with combined androgen blockade after the failure of this therapy
Obtain data that may predict more aggressive disease
OUTLINE This is a multicenter study
Patients receive finasteride and flutamide by mouth three times a day Patients experiencing recurrence or a greater than 4 numL above 50 increase in PSA level will discontinue flutamide treatments Otherwise patients continue therapy in the absence of unacceptable toxicity or disease progression
Quality of life is assessed prior to therapy and at 3 and 6 months
Patients are followed every 3 months for one year and every 6 months thereafter
PROJECTED ACCRUAL This study will accrue 100 patients over 2 years
Determine the efficacy of finasteride and flutamide in suppressing prostate specific antigen PSA levels in patients with elevated PSA after definitive radiation therapy or radical prostatectomy for prostate cancer
Assess sexual function and other quality of life issues during this therapy
Estimate the response to flutamide withdrawal in this group of patients who have not had a major reduction in circulating testosterone levels
Measure the response rate to further hormonal manipulation with combined androgen blockade after the failure of this therapy
Obtain data that may predict more aggressive disease
OUTLINE This is a multicenter study
Patients receive finasteride and flutamide by mouth three times a day Patients experiencing recurrence or a greater than 4 numL above 50 increase in PSA level will discontinue flutamide treatments Otherwise patients continue therapy in the absence of unacceptable toxicity or disease progression
Quality of life is assessed prior to therapy and at 3 and 6 months
Patients are followed every 3 months for one year and every 6 months thereafter
PROJECTED ACCRUAL This study will accrue 100 patients over 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CDR0000066274 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |