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

NCT00078923 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000353197P30CA022453WSU-C-2418
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage II prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (2)

• Oxidative DNA damage as measured by 5-hydroxymethyluridine level

  at 3 weeks

• Lipid oxidation as measured by 8-isoprostane level

  at 3 weeks

Secondary Outcomes (4)

• Tumor size, grade, and extension

  at 3 weeks

• Prostate-specific antigen and prostatic intraepithelial neoplasia grade

  at 3 weeks

• Biomarkers of cell growth, differentiation, and apoptosis

  at 3 weeks

• Toxicity as measured by number and grade of adverse events

  at 3 weeks

Study Arms (4)

Placebo

EXPERIMENTAL

Arm I (control group): Patients receive 4 placebo capsules by mouth daily for three weeks.

Procedure: neoadjuvant therapy; Other: Placebo

Soy isoflavones and placebo

EXPERIMENTAL

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; Other: Placebo

Soy Isoflavones/Placebo

EXPERIMENTAL

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; Other: Placebo

Soy Isoflavones

EXPERIMENTAL

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

Interventions

soy isoflavones DIETARY_SUPPLEMENT

Soy Isoflavones; Soy Isoflavones/Placebo; Soy isoflavones and placebo

neoadjuvant therapy PROCEDURE

Prostatectomy or Brachytherapy

Placebo; Soy Isoflavones/Placebo; Soy isoflavones and placebo

Placebo OTHER

Arm I: 4 placebo capsules Arm II: 3 placebo capsules Arm III: 2 placebo capsules

Placebo; Soy Isoflavones/Placebo; Soy isoflavones and placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Soybean Proteins; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Combined Modality Therapy; Therapeutics

Study Officials

• Omer Kucuk, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 9, 2004
• Study Start: November 1, 2001
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)