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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Pfizer |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00329043 |
Primary Objective:
1. To evaluate the pathological complete response (pCR) rate to neoadjuvant hormonal ablation and SU011248/sunitinib malate in high-risk localized prostate cancer.
Secondary Objectives:
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: LHRH Agonist Drug: Sunitinib Malate Procedure: Radical Prostatectomy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Neoadjuvant Trial of Sunitinib Malate (SU011248) Plus Hormonal Ablation for Patients Who Have High Risk Localized Prostate Cancer and Will Undergo Prostatectomy |
Estimated Enrollment: | 42 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Sunitinib + Hormonal Ablation Before Prostatectomy
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Drug: LHRH Agonist
Intramuscular injection either monthly for 3 months or in a single 3-month dose.
Drug: Sunitinib Malate
25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles.
Procedure: Radical Prostatectomy
Radical prostatectomy after completion of Sunitinib and LHRH agonist.
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Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Amado Zurita, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Amado Zurita, MD/Asst. Professor ) |
Study ID Numbers: | 2005-0903 |
Study First Received: | May 19, 2006 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00329043 |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer Adenocarcinoma of the Prostate Ductal Adenocarcinoma of the Prostate Hormonal Ablation Radical Prostatectomy |
LHRH Agonist Lupron Leuprolide Sunitinib Malate SU011248 |
Prostatic Diseases Genital Neoplasms, Male Leuprolide Sunitinib Urogenital Neoplasms |
Carcinoma, Ductal, Breast Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Antineoplastic Agents, Hormonal Antineoplastic Agents Growth Substances Physiological Effects of Drugs Reproductive Control Agents Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Fertility Agents, Female Fertility Agents Growth Inhibitors Angiogenesis Modulating Agents |