Overview

This trial is active, not recruiting.

Conditions adenocarcinoma of the prostate, recurrent prostate cancer, stage i prostate cancer, stage ii prostate cancer, stage iii prostate cancer
Treatments genistein, placebo, therapeutic conventional surgery
Phase phase 2
Sponsor Northwestern University
Collaborator National Cancer Institute (NCI)
Start date May 2010
End date May 2018
Trial size 36 participants
Trial identifier NCT01126879, NCI 09U2, NCI-2010-00941, P50CA090386, STU00019487

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
genistein CI 75610
Given orally
therapeutic conventional surgery
Radical prostatectomy for treatment of prostate cancer
(Placebo Comparator)
Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
placebo PLCB
Given orally
therapeutic conventional surgery
Radical prostatectomy for treatment of prostate cancer

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
Measure the effect of genistein on select gene and protein expressions in prostate tissue
time frame: At baseline and at time of surgery
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

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells
Principal investigator William Catalona
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Northwestern University.