Genistein in Treating Patients With Prostate Cancer

NCT01126879 | Terminated Phase 2 Results DMC FDA Drug

• 4 other identifiers: NCI 09U2NCI-2010-00941STU00019487P50CA090386
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery

Secondary Outcomes (3)

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

  At baseline, 1 and 12 months after surgery

• Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue

  At baseline and at time of surgery

• Measurement of PSA in Serum and Plasma by Nanotechnology

  At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery

Study Arms (2)

Arm I

EXPERIMENTAL

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

Dietary Supplement: genistein; Procedure: therapeutic conventional surgery

Arm II

PLACEBO COMPARATOR

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

Other: placebo; Procedure: therapeutic conventional surgery

Interventions

genistein DIETARY_SUPPLEMENT

Given orally

Also known as: CI 75610, Genestein, genisteol, genisterin, prunetol, sophoricol

Arm I

placebo OTHER

Given orally

Also known as: PLCB

Arm II

therapeutic conventional surgery PROCEDURE

Radical prostatectomy for treatment of prostate cancer

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Genistein

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The study was closed by an internal safety and data monitoring committee due to slow accrual of the study.

Results Point of Contact

• Title: William Catalona, MD
• Organization: Northwestern University

WCatalona@nm.org

312-695-1301

Study Officials

• William Catalona

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 20, 2010
• Study Start: February 3, 2011
• Primary Completion: May 9, 2013
• Study Completion: December 28, 2013
• Last Updated: September 10, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-04

Locations

US (1)