Sorafenib Tosylate and Gene Expression Analysis in Patients Undergoing Surgery For High-Risk Localized Prostate Cancer

NCT00466752 | Completed Phase 2 Results

• 2 other identifiers: 6307NCI-2010-00604
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying sorafenib tosylate and gene expression in patients undergoing surgery for high-risk localized prostate cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Studying samples of blood and tumor tissues in the laboratory from patients with prostate cancer may help doctors learn more about changes that occur in DNA after treatment with sorafenib tosylate

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Efficacy as Assessed by Number of Patients With Changes Across Transcript Profiles by Microarray Analysis in Prostate Cancer Specimens, Specifically Those With Complete Pathologic Response.

  Determined by changes across transcript profiles, by microarray analysis, in pre- versus post-treatment prostate cancer specimens (minimum 50 day time frame between these). Proportion of patients with complete pathologic response.

  Pre- versus post-treatment

Secondary Outcomes (2)

• Number of Participants With Complete Pathologic Response

  Day 1 of cycles 2 and 3, and day of radical prostatectomy. Each cycle is 2 weeks.

• Number of Participants With at Least 25% Reduction in PSA

  Day 1 of cycles 2 and 3 and on the day of radical prostatectomy. Each cycle is 2 weeks.

Study Arms (2)

Treatment (enzyme inhibitor) 48hr stop

EXPERIMENTAL

Patients receive sorafenib tosylate PO BID on days 1-14. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 days after completion of sorafenib tosylate, patients undergo radical prostatectomy on approximately day 43.

Drug: sorafenib tosylate; Genetic: microarray analysis; Other: immunohistochemistry staining method; Genetic: gene expression analysis; Procedure: needle biopsy; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Genetic: western blotting; Genetic: RNA analysis

Treatment (enzyme inhibitor) 24hr stop

EXPERIMENTAL

tients receive sorafenib tosylate PO BID on days 1-14. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 day after completion of sorafenib tosylate, patients undergo radical prostatectomy on approximately day 43.

Drug: sorafenib tosylate; Genetic: microarray analysis; Other: immunohistochemistry staining method; Genetic: gene expression analysis; Procedure: needle biopsy; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Genetic: western blotting; Genetic: RNA analysis

Interventions

sorafenib tosylate DRUG

Given PO

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

Treatment (enzyme inhibitor) 24hr stop; Treatment (enzyme inhibitor) 48hr stop

microarray analysis GENETIC

Correlative studies

Also known as: gene expression profiling

Treatment (enzyme inhibitor) 24hr stop; Treatment (enzyme inhibitor) 48hr stop

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Treatment (enzyme inhibitor) 24hr stop; Treatment (enzyme inhibitor) 48hr stop

gene expression analysis GENETIC

Correlative studies

Treatment (enzyme inhibitor) 24hr stop; Treatment (enzyme inhibitor) 48hr stop

needle biopsy PROCEDURE

Correlative studies

Also known as: aspiration biopsy, puncture biopsy

Treatment (enzyme inhibitor) 24hr stop; Treatment (enzyme inhibitor) 48hr stop

therapeutic conventional surgery PROCEDURE

Undergo prostatectomy

Treatment (enzyme inhibitor) 24hr stop; Treatment (enzyme inhibitor) 48hr stop

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor) 24hr stop; Treatment (enzyme inhibitor) 48hr stop

western blotting GENETIC

Correlative studies

Also known as: Blotting, Western, Western Blot

Treatment (enzyme inhibitor) 24hr stop; Treatment (enzyme inhibitor) 48hr stop

RNA analysis GENETIC

Correlative studies

Treatment (enzyme inhibitor) 24hr stop; Treatment (enzyme inhibitor) 48hr stop

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate
• Radical prostatectomy and lymph node dissection planned as primary therapy in a patient with acceptable surgical risk (e.g., cardiovascular, pulmonary, and functional status)
• year or longer life expectancy
• Any of the following high-risk features: Clinical stage T2b (palpable bilateral involvement) OR surgically resectable T3 OR PSA \>= 20 ng/ml OR overall Gleason grade \>= 8
• No evidence of bone metastases on bone scan
• No evidence of lymph nodes \>= 2 cm in diameter on pelvic CT scan
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Hemoglobin \>= 9.0 g/dl
• Absolute neutrophil count (ANC) \>= 1,500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Total bilirubin =\< 1.5 x ULN
• ALT =\< 2.5 x the ULN
• AST =\< 2.5 x the ULN
• INR =\< 1.5 and aPTT within normal limits
• Creatinine =\< 1.5 x ULN or creatinine clearance \> 60mL/min/1.73 m\^2

You may not qualify if:

• Prior therapy for prostate cancer including conventional androgen deprivation therapy, radiotherapy (external beam or brachytherapy), cryotherapy, and/or cytotoxic chemotherapy
• Any known metastasis; patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis
• Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
• Another malignancy, other than non-melanoma skin cancer, during the past 5 years
• History of bleeding diathesis or unexpected surgical bleeding
• Patients with active coagulopathy
• Cardiac disease: Congestive heart failure \> class II NYHA; patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Uncontrolled hypertension, as defined by systolic blood pressure consistently in excess of 150 mmHg, or diastolic pressure consistently in excess of 90 mmHg
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
• Pulmonary hemorrhage/bleeding event \>= CTCAE Grade 2 within 4 weeks of first dose of study drug
• Any other hemorrhage/bleeding event \>= CTCAE Grade 3 within 4 weeks of first dose of study drug
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
• Patients may not be concurrently receiving any chemotherapy, immunotherapy, hormonal therapy, or molecular targeted agents to treat their prostate cancer
• Patients may not be receiving any other investigational agents

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sorafenib; Microarray Analysis; Gene Expression Profiling; Immunohistochemistry; Biopsy, Needle; Blotting, Western

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)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Microchip Analytical Procedures; Investigative Techniques; Genetic Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Biopsy; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Electrophoresis; Chemistry Techniques, Analytical; Electrochemical Techniques; Immunoblotting; Immunoassay; Molecular Probe Techniques

Results Point of Contact

• Title: Evan Yu
• Organization: University of Washington / Seattle Cancer Care Alliance

evanyu@u.washington.edu

206-288-1152

Study Officials

• Evan Yu

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: December 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2011
• Last Updated: November 22, 2017
• Results First Posted: November 22, 2017

Record last verified: 2017-11

Locations

US (1)