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
  Purpose

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 Intervention Phase
Biochemical Recurrent Prostate Cancer
Dietary Supplement: Isoflavone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: November 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Florida

Additional 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
Study First Received: January 8, 2008
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014