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Genistein in Treating Patients With Prostate Cancer

Primary Purpose

Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
genistein
placebo
therapeutic conventional surgery
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.

Outcomes

Primary Outcome Measures

Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs
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.

Secondary Outcome Measures

Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy
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
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
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.

Full Information

First Posted
May 18, 2010
Last Updated
August 27, 2019
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01126879
Brief Title
Genistein in Treating Patients With Prostate Cancer
Official Title
Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Closed due to low accrual
Study Start Date
February 3, 2011 (Actual)
Primary Completion Date
May 9, 2013 (Actual)
Study Completion Date
December 28, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
Intervention Type
Dietary Supplement
Intervention Name(s)
genistein
Other Intervention Name(s)
CI 75610, Genestein, genisteol, genisterin, prunetol, sophoricol
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given orally
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Radical prostatectomy for treatment of prostate cancer
Primary Outcome Measure Information:
Title
Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs
Description
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.
Time Frame
At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Secondary Outcome Measure Information:
Title
Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy
Description
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.
Time Frame
At baseline, 1 and 12 months after surgery
Title
Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue
Description
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.
Time Frame
At baseline and at time of surgery
Title
Measurement of PSA in Serum and Plasma by Nanotechnology
Description
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.
Time Frame
At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Catalona
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Genistein in Treating Patients With Prostate Cancer

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