Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058266
Status:
TERMINATED
Last Update Posted:
2012-07-19
First Post:
2003-04-07
Brief Title:
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase II Study Of Genistein In Patients With Localized Prostate Cancer Molecular Correlates of Soy In Humans
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Data Monitoring Committee cited poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
PURPOSE Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy
PURPOSE Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy
Detailed Description:
OBJECTIVES
Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy
Determine the decrease if any of prostate-specific antigen-positive cells in the operative field of patients treated with this drug
Determine the quality of life of patients treated with this drug
OUTLINE Patients receive 1 of 2 treatment regimens
Group A Patients receive oral genistein once daily for 1-2 months undergo radical prostatectomy and then continue oral genistein once daily for 1-2 months afterward for a total of 3 months of therapy
Group B Patients undergo radical prostatectomy Beginning 1 month after surgery patients receive genistein as in arm I for 3 months
Quality of life is assessed at baseline and at 1 and 3 months after surgery
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 88 patients 44 patients per treatment group will be accrued for this study within 2 years
Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy
Determine the decrease if any of prostate-specific antigen-positive cells in the operative field of patients treated with this drug
Determine the quality of life of patients treated with this drug
OUTLINE Patients receive 1 of 2 treatment regimens
Group A Patients receive oral genistein once daily for 1-2 months undergo radical prostatectomy and then continue oral genistein once daily for 1-2 months afterward for a total of 3 months of therapy
Group B Patients undergo radical prostatectomy Beginning 1 month after surgery patients receive genistein as in arm I for 3 months
Quality of life is assessed at baseline and at 1 and 3 months after surgery
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 88 patients 44 patients per treatment group will be accrued for this study within 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 |
|---|---|---|---|
| NU-00U7 | None | None | None |