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Completed

NCT Number: NCT00596895

Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer

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)

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Key information

Conditions

Biochemical Recurrent Prostate Cancer Disease Attributes Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Recurrence Salivary Gland Adenoma, Pleomorphic Urogenital Diseases Urogenital Neoplasms

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida Shands

Jacksonville, Florida, 32209, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isoflavone

Dietary Supplement

Ingested 47 mg of isoflavone in three 8 oz servings per day

Other names: Soy Dream Enriched, Original or Vanilla, soy milk

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Jan 17, 2008
Registry last updated
Sep 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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