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Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy


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.

Inclusion 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., Centrumâ„¢) allowed

- No concurrent herbs

- No concurrent soy foods

- No other concurrent isoflavone supplements

- No other concurrent antineoplastic agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Oxidative DNA damage as measured by 5-hydroxymethyluridine level at 3 weeks

Safety Issue:

No

Principal Investigator

Omer Kucuk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000353197

NCT ID:

NCT00078923

Start Date:

November 2001

Completion Date:

May 2010

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • adenocarcinoma of the prostate
  • Adenocarcinoma
  • Prostatic Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201