Skip to content

Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer

Phase I Single and Multiple-Dose Safety and Pharmacokinetic Clinical Study of Genistein in Normal Volunteers and in Prostate Neoplasia (Multiple Dose Safety and Pharmacokinetic Clinical Study of Genistein in Prostate Neoplasia)

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00005827
Enrollment
0
Registered
2004-04-20
Start date
1999-12-31
Completion date
2003-05-31
Last updated
2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer

Brief summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase I trial to determine the effectiveness of genistein in treating patients who have stage II, stage III, or stage IV prostate cancer.

Detailed description

OBJECTIVES: I. Determine the safety and pharmacokinetics of genistein in patients with stage II, III, or IV prostate cancer. OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral genistein twice daily. Arm II: Patients receive oral placebo twice daily. Treatment continues for 3 months in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 6 months.

Interventions

DIETARY_SUPPLEMENTgenistein

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage B, C, or D adenocarcinoma of the prostate not amenable to surgery PATIENT CHARACTERISTICS: Age: 40 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases less than 4 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No significant abnormalities of internal organs, neurologic status, or biochemical levels No history of seizures No concurrent serious illness No acute infection requiring antibiotic therapy except chronic urinary tract infection No other prior or concurrent malignancy within the past 2 years except nonmelanoma carcinoma of the skin No history of substance abuse or addiction No alcohol intake greater than 2 drinks/day or 14 drinks/week No diet containing more than 20 mg of genistein/day No known soy intolerance No prior breast cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 3 months since prior hormonal therapy OR No concurrent estrogen Other concurrent hormonal therapy allowed if stable regimen for more than 3 months Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics At least 3 weeks since prior surgery and recovered Other: At least 6 weeks since prior antibiotics No concurrent genotoxicity therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026