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

NCT ID: NCT00672594

Last Updated: 2014-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2013-09-30

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.

Detailed Description

Eligible patients will be treated with 50 mg once daily for four weeks followed by one to two weeks off treatment prior to undergoing radical prostatectomy. Patients with palpable disease (cT2-3) and patients with 3 or more positive prostatic biopsies from one lobe may undergo an additional study of IFP monitoring before treatment and during week 4 of study treatment. Safety and tolerability of Sunitinib malate therapy at this dose and schedule in this patient population will be assessed. Extensive correlative science evaluations, including assessment of physiologic, cellular, molecular and genetic changes during treatment with Sunitinib malate, will be performed

Conditions

Prostate Cancer; Prostatectomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sunitinib Malate

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

Group Type: EXPERIMENTAL

Sunitinib Malate

Intervention Type: DRUG

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

Interventions

Sunitinib Malate

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

Intervention Type: DRUG

Other Intervention Names

Sutent

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel J George, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

MD Anderson, University of Texas

Houston, Texas, United States

Countries

United States

Other Identifiers

DUMC-8725

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00007396

Identifier Type: -

Identifier Source: org_study_id