Clinical trial NCT00672594: Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Official title: Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Prostatectomy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-05-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in Apoptotic Indices Before and After Treatment
timeFrame: Baseline and 4 weeks
measure: Change in Proliferation Indices Before and After Treatment
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Number of Patients Experiencing Grade ≥4 Hematologic or Grade ≥3 Non-hematologic Toxicity
timeFrame: 4 years
measure: Change in Pathologic (Microvessel Density).
timeFrame: Baseline and 4 weeks
measure: Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
timeFrame: Baseline and 4 weeks
measure: Protein Levels and Activation Status of PDGFR in Prostate Cancer Tissue.
timeFrame: 4 years
measure: Difference in Gene Expression Patterns Using Microarray Analysis
timeFrame: 4 years
measure: Interstitial Fluid Pressure (IFP)
timeFrame: 4 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: MD Anderson, University of Texas
state: Texas
Study officials:
affiliation: Duke University
name: Daniel J George, MD
role: PRINCIPAL_INVESTIGATOR
References: