Clinical trial · Interventional
Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
NCT00672594CI-TRIAL-00015297completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib Malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib Malate
- description
- Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
- interventionNames
- Drug: Sunitinib Malate
Primary outcomes (2)
- measure
- Change in Apoptotic Indices Before and After Treatment
- timeFrame
- Baseline and 4 weeks
- description
- Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %apoptosis (measured as %TUNEL positive cells per high powered field) between pre and post treatment will be reported.
- measure
- Change in Proliferation Indices Before and After Treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.