Clinical Trial Details

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Study ID NCI 09U2
Investigator
William Catalona,   Northwestern University
Title Genistein in Treating Patients With Prostate Cancer
Conditions Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage III Prostate Cancer
Interventions Dietary Supplement: genistein
Other: placebo
Procedure: therapeutic conventional surgery
Phase Phase 2
Purpose RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion
  • Participants must have a pathologic diagnosis of prostate cancer within the past 6 months, have clinical stage T1-3 disease, PSA >= 10, Gleason score >= 8, and have elected to undergo radical prostatectomy; those found to have detectable circulating prostate cancer cells in the blood as detected by qRT-PCR for PSA will be eligible to proceed onto the treatment phase of the protocol; pathology slides used for diagnosis will be submitted to the SPORE tissue pathology core for review
  • ECOG performance status 0-1
  • Hemoglobin > 9.0gm/dl
  • Platelets >= 100 K/uL
  • ANC > 1000/uL
  • AST (SGOT)/ALT (SGPT) < 3X upper limit of normal
  • Creatinine < 2.0 mg/dl
  • Total bilirubin < 2 mg/dl (Note: Subjects with a higher level of bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)
  • Participants must agree not to take soy supplements
  • Ability to understand and the willingness to sign a written informed consent document
  • Willingness to take study agent for at least 2 weeks prior to radical prostatectomy Exclusion
  • History of venous thrombosis within past year
  • Participants must not be receiving active therapy for neoplastic disorders (including hormone or radiation therapy for prostate cancer)
  • Participants may not be receiving any other investigational agents
  • Known soy intolerance
  • Medical conditions that, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained
  • Study Location
    Northwestern University
    Chicago, Illinois, 60611
    Contact N/A

    Information objtained from ClinicalTrials.gov, on 7/23/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT01126879


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