Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer
- Conditions
- Biochemical Recurrent Prostate Cancer
- Interventions
- Dietary Supplement: Isoflavone
- Registration Number
- NCT00596895
- Lead Sponsor
- University of Florida
- 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)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- Raising serum PSA profile after previous definitive therapy (e.g., radical prostatectomy or external beam radiation therapy).
- Life expectancy of at least one year and performance status of <2 of Zubrod scale.
- Metastatic or locally recurrent disease demonstrated on bone scan, computed tomography or transrectal ultrasound, or be clinically symptomatic at the time of enrollment
- No androgen deprivation therapy (ADT) or chemotherapy within 12 months of entry into the study.
- Known allergic reaction to milk or soy products were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Isoflavone Isoflavone treatment
- Primary Outcome Measures
Name Time Method Assess the effect of soy protein/isoflavones serum PSA levels in patients previously treated with radical prostatectomy and external beam radiation therapy. Baseline, 3, 6, 9 and 12 months
- Secondary Outcome Measures
Name Time Method Assess the effect of soy protein/isoflavones on serum testosterone, isoflavone metabolites, and cholesterol. Assess the effect of soy protein/isoflavones on quality of life of these patients. Baseline, 3, 6, 9 and 12 months
Trial Locations
- Locations (1)
University of Florida Shands
🇺🇸Jacksonville, Florida, United States