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Study ID
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NCI 09U2
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Investigator
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William Catalona, Northwestern University
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Title
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Genistein in Treating Patients With Prostate Cancer
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Conditions
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Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage III Prostate Cancer
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Interventions
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Dietary Supplement: genistein
Other: placebo
Procedure: therapeutic conventional surgery
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Phase
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Phase 2
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Purpose
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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.
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Eligibility
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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
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Study Location
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N/A
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Contact
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William Catalona, MD
312-695-6124
wcatalona@nmff.org
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Information obtained from ClinicalTrials.gov, on
6/19/2013. For additional information about
this and other clinical trials,
visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier:
NCT01126879