Clinical trial NCT00058266: Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
Official title: A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage II prostate cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-04-09
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Toxicity
timeFrame: At surgery & monthly thereafter during treatment (3 mos)
measure: Decrease in prostate-specific antigen-positive cells
timeFrame: At time of surgery
measure: Alteration in cell morphology
timeFrame: At time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Veterans Affairs Medical Center - Lakeside Chicago
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare - Evanston Hospital
state: Illinois
city: Harvey
country: United States
facility: Ingalls Cancer Care Center at Ingalls Memorial Hospital
state: Illinois
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Raymond C. Bergan, MD
role: STUDY_CHAIR
References: