Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy

NCT00672594 | Completed Phase 2 Results

• 2 other identifiers: Pro00007396DUMC-8725
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to look at blood and tissue samples for changes following the use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors of intestines and kidney but it is being tested in research studies for use in men with prostate cancer.

Conditions

Prostate Cancer; Prostatectomy

Outcome Measures

Primary Outcomes (2)

• Change in Apoptotic Indices Before and After Treatment

  Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %apoptosis (measured as %TUNEL positive cells per high powered field) between pre and post treatment will be reported.

  Baseline and 4 weeks

• Change in Proliferation Indices Before and After Treatment

  Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %proliferation (Ki67 positive nuclei out of total nuclei) between pre and post treatment will be reported.

  Baseline and 4 weeks

Secondary Outcomes (6)

• Number of Patients Experiencing Grade ≥4 Hematologic or Grade ≥3 Non-hematologic Toxicity

  4 years

• Change in Pathologic (Microvessel Density).

  Baseline and 4 weeks

• Change in Systemic Parameters Before and After Sunitinib Malate Treatment.

  Baseline and 4 weeks

• Protein Levels and Activation Status of PDGFR in Prostate Cancer Tissue.

  4 years

• Difference in Gene Expression Patterns Using Microarray Analysis

  4 years

Study Arms (1)

Sunitinib Malate

EXPERIMENTAL

Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks

Drug: Sunitinib Malate

Interventions

Sunitinib Malate DRUG

Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks

Also known as: Sutent

Sunitinib Malate

Eligibility Criteria

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

You may qualify if:

• Histologic evidence of adenocarcinoma of the prostate deemed candidates for curative RRP
• Intermediate or high risk, clinically localized disease
• Adequate organ function
• Patients must be surgically sterile or must agree to use effective contraception during the period of therapy
• Select imaging to rule out metastasis will be done as clinically indicated
• Signed and date informed consent document

You may not qualify if:

• Prior treatment for prostate cancer
• Major surgery or radiation therapy within 4 weeks of starting the study treatment
• NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy
• History of or known metastatic prostate cancer
• Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
• Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater
• QTc interval \> 500 msec on baseline EKG
• Hypertension that cannot be controlled by medications (\>150/100 mm Hg despite optimal medical therapy).
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
• Known active infection
• Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

Sponsors & Collaborators

• Duke University: lead
• Pfizer: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MD Anderson, University of Texas

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sunitinib

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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Daniel George
• Organization: Duke University

daniel.george@duke.edu

919-668-4615

Study Officials

• Daniel J George, MD

  Duke University

  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: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2008
• First Posted: May 6, 2008
• Study Start: July 1, 2006
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2013
• Last Updated: August 4, 2014
• Results First Posted: June 16, 2014

Record last verified: 2014-05

Locations

US (2)