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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

Detailed Description:
  • 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.
Study Start Date : November 2003
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Isoflavone treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Florida
University of Florida Shands
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Charles J. Rosser, MD University of Florida
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00596895     History of Changes
Other Study ID Numbers: UFJ2003-113
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: January 2008

Keywords provided by University of Florida:
Isoflavone, PSA, prostate cancer, recurrent, quality of life

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases