Genistein in Treating Patients With Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01126879 |
Recruitment Status
:
Active, not recruiting
First Posted
: May 20, 2010
Last Update Posted
: December 13, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer | Dietary Supplement: genistein Other: placebo Procedure: therapeutic conventional surgery | Phase 2 |
PRIMARY OBJECTIVES:
I. Determine whether genistein treatment will decrease the number of circulating prostate cells (CPCs) in the peripheral blood as measured by qRT-PCR for PSA performed on RNA extracted from peripheral blood mononuclear cells (PBMNCs).
SECONDARY OBJECTIVES:
I. Determine the natural history of circulating prostate cells (CPCs) in a cohort of subjects prior to and post radical prostatectomy.
II. Compare the measurement of PSA between three separate methods: in CPCs by qRT-PCR, in serum by the standard clinical chemistry assay (i.e., ELISA), and in plasma and serum by the nano-PSA assay.
III. Measure the effect of genistein on gene and protein expression in prostate tissue by qRT-PCR and immunohistochemistry, respectively, for the following genes and their respective protein products: HSP27, MMP-2, ALK-2, BASP1, and HCF2.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
ARM II: Patients receive oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
All patients undergo radical prostatectomy at least 2 weeks, but not more than 3 months following the start of therapy.
After completion of study treatment, patients are followed at 1, 6, and 12 months.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells |
Study Start Date : | May 2010 |
Estimated Primary Completion Date : | May 2018 |
Estimated Study Completion Date : | May 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I
Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
|
Dietary Supplement: genistein
Given orally
Other Names:
Procedure: therapeutic conventional surgery
Radical prostatectomy for treatment of prostate cancer
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Placebo Comparator: Arm II
Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
|
Other: placebo
Given orally
Other Name: PLCB
Procedure: therapeutic conventional surgery
Radical prostatectomy for treatment of prostate cancer
|
- Determine whether genistein will decrease number of circulating prostate cells (CPCs) in the blood as determined by qRT-PCR for PSA on RNA extracted from PBMNCs [ Time Frame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery ]Blood will be collected to analyze the number of CPC's at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.
- Determine the natural history of circulating prostate cells (CPCs) in a cohort of subjects prior to and post radical prostatectomy [ Time Frame: At baseline, 1 and 12 months after surgery ]Blood will be drawn to analyze the natural history of circulating prostate cells (CPCs) in a cohort of subjects at baseline and 1 and 12 months after surgery.
- Measure the effect of genistein on select gene and protein expressions in prostate tissue [ Time Frame: At baseline and at time of surgery ]At baseline and time of surgery, tissue will be collected to measure the effect of genistein on select gene and protein expressions in prostate tissue.
- Measurement of PSA in serum and plasma by nanotechnology [ Time Frame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery ]Blood will be collected to measure PSA in serum and plasma by nanotechnology at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126879
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | William Catalona | Northwestern University |
Responsible Party: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT01126879 History of Changes |
Other Study ID Numbers: |
NCI 09U2 NCI-2010-00941 STU00019487 ( Other Identifier: Northwestern University IRB ) P50CA090386 ( U.S. NIH Grant/Contract ) |
First Posted: | May 20, 2010 Key Record Dates |
Last Update Posted: | December 13, 2017 |
Last Verified: | December 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Prostatic Neoplasms Adenocarcinoma Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Genistein |
Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Phytoestrogens Estrogens, Non-Steroidal Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |