Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

University of Florida20 enrolled

Overview

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)

* 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Biochemical Recurrent Prostate Cancer

Interventions

IsoflavoneDIETARY_SUPPLEMENT

Ingested 47 mg of isoflavone in three 8 oz servings per day

Eligibility

Sex: MALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

University of Florida Shands

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Assess the effect of soy protein/isoflavones serum PSA levels in patients previously treated with radical prostatectomy and external beam radiation therapy.

Time frame: Baseline, 3, 6, 9 and 12 months

Secondary Outcomes

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.

Time frame: Baseline, 3, 6, 9 and 12 months

Data from ClinicalTrials.gov

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