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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer, Prostatectomy

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Trial Information

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

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

Inclusion Criteria:

- Histologic evidence of adenocarcinoma of the prostate deemed candidates for curative

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Apoptotic and proliferation indices demonstrated by pathologic measures in prostate cancer specimens before and after Sunitinib Malate treatment.

Outcome Time Frame:

Before treatment and post surgery

Safety Issue:


Principal Investigator

Daniel J George, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Institutional Review Board

Study ID:

Pro00007396 (DUMC-8725)



Start Date:

July 2006

Completion Date:

September 2013

Related Keywords:

  • Prostate Cancer
  • Prostatectomy
  • Prostatic Neoplasms



Duke University Medical Center Durham, North Carolina  27710
MD Anderson, University of Texas Houston, Texas