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Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00596895
First received: January 8, 2008
Last updated: September 16, 2011
Last verified: January 2008

January 8, 2008
September 16, 2011
November 2003
November 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00596895 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer
Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Biochemical Recurrent Prostate Cancer
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
Experimental: 1
Isoflavone treatment
Intervention: Dietary Supplement: Isoflavone
Pendleton JM, Tan WW, Anai S, Chang M, Hou W, Shiverick KT, Rosser CJ. Phase II trial of isoflavone in prostate-specific antigen recurrent prostate cancer after previous local therapy. BMC Cancer. 2008 May 11;8:132.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2007
November 2007   (final data collection date for primary outcome measure)

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.
Male
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00596895
UFJ2003-113
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Charles J. Rosser, MD University of Florida
University of Florida
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP