Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Biochemical Recurrent Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: Isoflavone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Isoflavone treatment | Dietary Supplement: Isoflavone<br>* Ingested 47 mg of isoflavone in three 8 oz servings per day<br>* Other names: Soy Dream Enriched, Original or Vanilla, soy milk;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isoflavone, PSA, prostate cancer, recurrent, quality of life