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Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy

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Northwestern University

Status and phase

Terminated
Phase 2

Conditions

Prostate Cancer

Treatments

Dietary Supplement: genistein
Procedure: conventional surgery

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00058266
NU 00U7
NU-00U7

Details and patient eligibility

About

RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.

Full description

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.

Enrollment

36 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

Group A
Experimental group
Description:
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).
Treatment:
Dietary Supplement: genistein
Procedure: conventional surgery
Group B
Experimental group
Description:
Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
Treatment:
Dietary Supplement: genistein
Procedure: conventional surgery

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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