MDACC Study Summary 2005-0903

Study Summary
No. 2005-0903:.......Prostate......Amado Zurita......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2005-0903

Study 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

Physician

New Patient Referral



Name:	Amado Zurita	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	While on study, the patient must return every 14 days. Patients having surgery must return 3 months post-operatively for follow-up.

Treatment Agents:	SU011248	Home Care:	The SU011248/sunitinib malate capsule should be taken orally once daily for 3 months. A 2-week course of bicalutamide orally once daily will be permitted for patients starting LHRH agonist therapy and suspected to be at risk for tumor flare.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if the addition of sunitinib malate (SU011248) to hormone based castration is an effective treatment for shrinking or controlling the tumor before having the prostate removed.

Study Objectives / Outcomes

Primary

1. To evaluate the pathological complete response (pCR) rate to neoadjuvant hormonal ablation and SU011248/sunitinib malate in high-risk localized prostate cancer.

Secondary
1. To evaluate the time to PSA-progression after neoadjuvant hormonal ablation and SU011248/sunitinib malate, and Radical Prostatectomy (RP), in high-risk localized prostate cancer.

2. To evaluate the perioperative and postoperative morbidity with RP after neoadjuvant hormonal ablation and SU011248/sunitinib malate.

3. To identify and measure molecular biomarkers for neoadjuvant hormonal ablation and SU011248/sunitinib malate (optional studies).

Study Status Information



Study Activation / Registration Date:	05/15/2006

IRB Review and Approval Date:	12/21/2005

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with histologically confirmed adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. Ductal adenocarcinoma of the prostate is included.

2) All patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.

3) All patients must have one of the following high-risk features: clinical (c) T(subscript)3 disease or Gleason 8-10 adenocarcinoma or cT(subscript)2(subscript)b-c and PSA >= 10 ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed.

4) ECOG performance status 0 or 1.

5) Prior hormonal therapy up to 2 months is permitted.

6) Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >= 1,500/mm^3 and platelet count of >= 100,000/mm^3; hemoglobin >= 9.0g/dl; adequate hepatic function defined as a total bilirubin of <=1.5 mg/dl and AST/ALT <= 2 x the upper limit of normal; adequate renal function defined as serum creatinine <= 1.5 x the upper limits of normal or creatinine clearance >= 40cc/min (measured or calculated).

7) Patients must sign the current IRB approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.

8) All patients must have a surgical and medical oncology consult prior to signing informed consent.

Exclusion Criteria:

1) Patients with small cell or sarcomatoid prostate cancers are not eligible.

2) Patients with clinical or radiological evidence of metastatic disease.

3) Patients receiving ketoconazole as a prior hormonal therapy.

4) Prior chemotherapy or experimental agents for prostate cancer.

5) Patients with any infection process, in the criterion of the investigator, that could worsen or its outcome be affected, as a result of the investigational therapy.

6) Patients with NYHA Class III/IV congestive heart failure, unstable angina, cerebrovascular accident or transient ischemic attack, or pulmonary embolism or myocardial infarction in the last 6 months.

7) Uncontrolled severe hypertension (>= 140/90 despite controlling medication), uncontrolled diabetes mellitus, oxygen-dependent lung disease, known chronic liver disease or HIV infection.

8) Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.

9) Ongoing treatment with therapeutic doses of coumadin. However, low dose coumadin up to 2mg PO daily for deep vein thrombosis prophylaxis is allowed. Low molecular weight heparin is allowed.

10) Overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.

Links

Registration Number: NCT00329043
Study Information on Clinical Trials Registry (clinicaltrials.gov)