NCT00596895

Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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)

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.

Conditions

• Biochemical Recurrent Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Isoflavone	Ingested 47 mg of isoflavone in three 8 oz servings per day

Timeline

• Start date: 2003-11-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2008-01-17
• Last updated: 2011-09-20

Locations

1 site across 1 country: United States