Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy
|ClinicalTrials.gov Identifier: NCT00329043|
Recruitment Status : Active, not recruiting
First Posted : May 24, 2006
Last Update Posted : October 6, 2017
|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.
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|