Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
Study NCT ID:
NCT00058266
Status:
TERMINATED
Last Update Posted:
2012-07-19
First Post:
2003-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
Sponsor:
Northwestern University
Organization:
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NU-00U7 | None | None | View |