Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy
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|ClinicalTrials.gov Identifier: NCT00329043|
Recruitment Status : Active, not recruiting
First Posted : May 24, 2006
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: LHRH Agonist Drug: Sunitinib Malate Procedure: Radical Prostatectomy||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 2006|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Sunitinib + Hormonal Ablation Before Prostatectomy
Sunitinib Malate 25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles. LHRH Agonist intramuscular injection either monthly for 3 months or in a single 3-month dose. Radical prostatectomy after completion of Sunitinib and LHRH agonist.
Drug: LHRH Agonist
Intramuscular injection either monthly for 3 months or in a single 3-month dose.
Other Names:Drug: Sunitinib Malate
25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles.
Other Name: SU011248Procedure: Radical Prostatectomy
Radical prostatectomy after completion of Sunitinib and LHRH agonist.
- Number of Participants With Pathological Complete Response (pCR) [ Time Frame: Surgery following 3 months of therapy. ]Response defined as pathological complete remission based on operative findings and tissue obtained at surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329043
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Amado Zurita, MD||M.D. Anderson Cancer Center|