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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00672594
First received: May 4, 2008
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Prostatectomy
 Drug: Sunitinib Malate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Apoptotic and proliferation indices demonstrated by pathologic measures in prostate cancer specimens before and after Sunitinib Malate treatment. [ Time Frame: Before treatment and post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstrate that Sunitininb Malate is safe and tolerable in patients who will be undergoing radical prostatectomy. [ Time Frame: Day 15, 29, and post surgery follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: July 2006
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Only study arm; treatment arm.
 Drug: Sunitinib Malate
50mg daily x 4 weeks
Other Name: Sutent

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672594

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
MD Anderson, University of Texas
Houston, Texas, United States
Sponsors and Collaborators
Duke University
Pfizer
Investigators
Principal Investigator: Daniel J George, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00672594     History of Changes
Other Study ID Numbers: Pro00007396 (DUMC-8725)
Study First Received: May 4, 2008
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sunitinib
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013