Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-29 @ 12:15 PM
Study NCT ID:
NCT00596895
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2008-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.
Status:
COMPLETED
Status Verified Date:
2008-01
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:
Primary Outcome Measures:
Decrease in rate of serum PSA rise
Secondary Outcome Measures:
Adherence to treatment regimens
Quality of life as assessed by FACT-P at baseline and at 12 months of treatment
Modulation of serum testosterone,isoflavone metabolites, and cholesterol
Estimated Enrollment: 27 Study Start Date: November 2003 Estimated Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Decrease in rate of serum PSA rise
Secondary Outcome Measures:
Adherence to treatment regimens
Quality of life as assessed by FACT-P at baseline and at 12 months of treatment
Modulation of serum testosterone,isoflavone metabolites, and cholesterol
Estimated Enrollment: 27 Study Start Date: November 2003 Estimated Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:
* Pretreatment evaluation included a complete medical history, physical examination (including digital rectal examination), serum PSA, free/total testosterone, lipids, serum isoflavone levels (genistein, daidzein, and equol), and assessment of quality of life (Functional Assessment of Cancer Treatment-Prostate, FACT-P questionnaire).
* Whole blood will be obtained prior to initiation of the study to assess for DNA polymorphism.
* Follow-up serum PSA levels to assess efficacy were obtained at 3, 6, 9, and 12 months after initiation of treatment.
* Medical history, physical examination, serum testosterone, lipids, isoflavone, and quality of life were assessed at 6 and 12 months after initiation of treatment.
* Whole blood will be obtained prior to initiation of the study to assess for DNA polymorphism.
* Follow-up serum PSA levels to assess efficacy were obtained at 3, 6, 9, and 12 months after initiation of treatment.
* Medical history, physical examination, serum testosterone, lipids, isoflavone, and quality of life were assessed at 6 and 12 months after initiation of treatment.
Study Oversight
Has Oversight DMC:
False
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?: