Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00078923
First received: March 8, 2004
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the development of early cancer. Soy isoflavones may be effective in delaying the development of early prostate cancer.

PURPOSE: This randomized phase II trial is studying different regimens of soy isoflavones to compare how well they work in treating patients who are undergoing radical prostatectomy for stage I or stage II prostate cancer (adenocarcinoma).


Condition Intervention Phase
Prostate Cancer
Dietary Supplement: soy isoflavones
Procedure: neoadjuvant therapy
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Oxidative DNA damage as measured by 5-hydroxymethyluridine level [ Time Frame: at 3 weeks ] [ Designated as safety issue: No ]
  • Lipid oxidation as measured by 8-isoprostane level [ Time Frame: at 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor size, grade, and extension [ Time Frame: at 3 weeks ] [ Designated as safety issue: No ]
  • Prostate-specific antigen and prostatic intraepithelial neoplasia grade [ Time Frame: at 3 weeks ] [ Designated as safety issue: No ]
  • Biomarkers of cell growth, differentiation, and apoptosis [ Time Frame: at 3 weeks ] [ Designated as safety issue: No ]
  • Toxicity as measured by number and grade of adverse events [ Time Frame: at 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: November 2001
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
Arm I (control group): Patients receive 4 placebo capsules by mouth daily for three weeks.
Procedure: neoadjuvant therapy
Prostatectomy or Brachytherapy
Other: Placebo
Arm I: 4 placebo capsules Arm II: 3 placebo capsules Arm III: 2 placebo capsules
Experimental: Soy isoflavones and placebo
Arm II: Patients receive oral soy isoflavones (PTI G-2535) 150 mg genistein capsules + 3 placebo capsules by mouth daily for 3 weeks.
Dietary Supplement: soy isoflavones Procedure: neoadjuvant therapy
Prostatectomy or Brachytherapy
Other: Placebo
Arm I: 4 placebo capsules Arm II: 3 placebo capsules Arm III: 2 placebo capsules
Experimental: Soy Isoflavones/Placebo
Arm III: Patients receive oral soy isoflavones (PTI G-2535) 300 mg genistein capsules + 2 placebo capsules by mouth daily for 3 weeks.
Dietary Supplement: soy isoflavones Procedure: neoadjuvant therapy
Prostatectomy or Brachytherapy
Other: Placebo
Arm I: 4 placebo capsules Arm II: 3 placebo capsules Arm III: 2 placebo capsules
Experimental: Soy Isoflavones
Arm IV: Arm III: Patients receive oral soy isoflavones (PTI G-2535) 600 mg genistein capsules by mouth daily for 3 weeks.
Dietary Supplement: soy isoflavones

Detailed Description:

OBJECTIVES:

  • Compare blood/prostate biomarkers of oxidative stress and prostate cancer risk in patients with stage I or II adenocarcinoma of the prostate treated with 3 different dose levels of soy isoflavones before radical prostatectomy.
  • Compare prostatic tissue biomarkers of proliferation and apoptosis in patients treated with these regimens.
  • Determine the potential response, in terms of tumor and prostatic intraepithelial neoplasia grade and volume, extraprostatic extension, and serum prostate-specific antigen level, in patients treated with soy isoflavones and in those treated with placebo.
  • Determine the safety of soy isoflavone supplementation in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study. Patients are stratified according to tumor stage (T1c vs T2). Patients are randomized to 1 of 4 treatment arms.

  • Arm I (control group): Patients receive oral placebo once daily.
  • Arm II: Patients receive oral soy isoflavones and oral placebo once daily.
  • Arm III: Patients receive a higher dose of oral soy isoflavones and oral placebo once daily.
  • Arm IV: Patients receive a higher dose (higher than arm III) of oral soy isoflavones once daily.

In all arms, treatment continues for 2-6 weeks (depending on the time from study entry to planned surgery) in the absence of unacceptable toxicity. All patients then undergo radical prostatectomy.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study within 12.5 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Stage T1c or T2
    • Disease confined to the prostate gland
  • Planning to undergo radical prostatectomy within the next 3-4 weeks

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • ALT and AST less than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2 times ULN

Renal

  • Not specified

Other

  • Fertile patients must use effective barrier contraception
  • Medically cleared for surgery
  • No concurrent thyroid disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biological therapy for prostate cancer
  • No concurrent biological agents

Chemotherapy

  • No prior chemotherapy for prostate cancer
  • No concurrent chemotherapy

Endocrine therapy

  • No prior hormonal therapy for prostate cancer
  • No concurrent thyroid hormone replacement medication
  • No concurrent hormonal therapy

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • At least 3 months since prior high-dose nutritional supplements
  • No concurrent regular use (more than once weekly) of soy products greater than 50 g of soy protein or 50 mg of soy isoflavone
  • No concurrent high-dose nutritional supplements

    • Standard-dose single multivitamin tablet (e.g., Centrum™) allowed
  • No concurrent herbs
  • No concurrent soy foods
  • No other concurrent isoflavone supplements
  • No other concurrent antineoplastic agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078923

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Omer Kucuk, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00078923     History of Changes
Other Study ID Numbers: CDR0000353197, P30CA022453, WSU-C-2418
Study First Received: March 8, 2004
Last Updated: March 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage I prostate cancer
stage II prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014