Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

Completed · Phase 2

Conditions studied: Biochemical Recurrent Prostate Cancer

In brief

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)

Key facts

Study ID

NCT00596895

Run by

University of Florida

People needed

20

Starts

2003-11-01

Expected to finish

2007-11-01

Last updated by the study team

2011-09-20

Who can join

Age: 45 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Florida Shands — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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