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

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer; Prostatectomy

Intervention: Sunitinib Malate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Daniel J George, MD, Principal Investigator, Affiliation: Duke University

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.

Clinical Details

Official title: Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change in Apoptotic Indices Before and After Treatment

Change in Proliferation Indices Before and After Treatment

Secondary outcome:

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

Change in Pathologic (Microvessel Density).

Change in Systemic Parameters Before and After Sunitinib Malate Treatment.

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

Difference in Gene Expression Patterns Using Microarray Analysis

Interstitial Fluid Pressure (IFP)

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.

Locations and Contacts

Duke University Medical Center, Durham, North Carolina 27710, United States

MD Anderson, University of Texas, Houston, Texas 77030, United States

Additional Information

Starting date: July 2006
Last updated: July 31, 2014

Page last updated: August 23, 2015

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