Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00596895|
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : September 20, 2011
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)
|Condition or disease||Intervention/treatment||Phase|
|Biochemical Recurrent Prostate Cancer||Dietary Supplement: Isoflavone||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
Dietary Supplement: Isoflavone
Ingested 47 mg of isoflavone in three 8 oz servings per day
Other Name: Soy Dream Enriched, Original or Vanilla, soy milk
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596895
|United States, Florida|
|University of Florida Shands|
|Jacksonville, Florida, United States, 32209|
|Principal Investigator:||Charles J. Rosser, MD||University of Florida|