Last reviewed · How we verify
Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.
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)
Details
| Lead sponsor | University of Florida |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2003-11 |
| Completion | 2007-11 |
Conditions
- Biochemical Recurrent Prostate Cancer
Interventions
- Isoflavone
Primary outcomes
- 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
Countries
United States