Clinical trial NCT01126879: Genistein in Treating Patients With Prostate Cancer
Official title: Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage III Prostate Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-20
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs
timeFrame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Secondary outcomes:
measure: Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy
timeFrame: At baseline, 1 and 12 months after surgery
measure: Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue
timeFrame: At baseline and at time of surgery
measure: Measurement of PSA in Serum and Plasma by Nanotechnology
timeFrame: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: William Catalona
role: PRINCIPAL_INVESTIGATOR
References: