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A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)


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

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Trial Information

A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)


OBJECTIVES:

- Determine the toxicity of genistein in patients with localized prostate cancer treated
with radical prostatectomy.

- Determine the decrease, if any, of prostate-specific antigen-positive cells in the
operative field of patients treated with this drug.

- Determine the quality of life of patients treated with this drug.

OUTLINE: Patients receive 1 of 2 treatment regimens.

- Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical
prostatectomy, and then continue oral genistein once daily for 1-2 months afterward
(for a total of 3 months of therapy).

- Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery,
patients receive genistein as in arm I for 3 months.

Quality of life is assessed at baseline and at 1 and 3 months after surgery.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 88 patients (44 patients per treatment group) will be accrued
for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of localized prostate cancer

- Diagnosed within the past 6 months

- T1 or T2 disease

- Gleason score 5-8

- Prostate-specific antigen no greater than 20 ng/mL

- Radical prostatectomy planned

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- More than 2 years

Hematopoietic

- Hemoglobin greater than 9.0 g/dL

- Platelet count greater than 100,000/mm^3

- Absolute neutrophil count greater than 1,000/mm^3

Hepatic

- SGPT and SGOT less than 3 times normal

- Bilirubin less than 3 mg/dL (less than 1.5 times normal) (patients with an elevated
bilirubin due to a familial defect in bilirubin metabolism will be considered on an
individual basis)

Renal

- Creatinine less than 2.0 mg/dL

Cardiovascular

- No venous thrombosis within the past year

Other

- Patients must use effective barrier contraception

- No other medical condition that would preclude study therapy

- No known soy intolerance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- No concurrent hormonal therapy for prostate cancer

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

Other

- No concurrent soy supplements

- No concurrent foods high in genistein

- No concurrent active therapy for neoplastic disorders

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Outcome Time Frame:

At surgery & monthly thereafter during treatment (3 mos)

Safety Issue:

Yes

Principal Investigator

Raymond C. Bergan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 00U7

NCT ID:

NCT00058266

Start Date:

December 2002

Completion Date:

September 2009

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • Prostatic Neoplasms

Name

Location

Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois  60201-1781
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
University of Washington School of MedicineSeattle, Washington  98195
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426