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

Duke University

Status and phase

Completed

Phase 2

Conditions

Prostatectomy

Prostate Cancer

Treatments

Drug: Sunitinib Malate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00672594

DUMC-8725 (Other Identifier)

Pro00007396

Details and patient eligibility

About

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.

Full 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

Enrollment

30 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.