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Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: M.D. Anderson Cancer Center
Pfizer
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00329043
  Purpose

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:

  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).

Condition Intervention Phase
Prostate Cancer
Drug: LHRH Agonist
Drug: Sunitinib Malate
Procedure: Radical Prostatectomy
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

ChemIDplus related topics:   Sunitinib    Sunitinib malate    Leuprolide acetate    Leuprolide    Gonadorelin    Gonadorelin hydrochloride    LH-RH    Malic acid   

U.S. FDA Resources

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:   42
Study Start Date:   May 2006
Estimated Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Sunitinib + Hormonal Ablation Before Prostatectomy
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.

Show detailed description  Show Detailed Description

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329043

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer

Investigators
Principal Investigator:     Amado Zurita, MD     U.T.M.D. Anderson Cancer Center    
  More Information


Responsible Party:   U.T. M.D. Anderson Cancer Center ( Amado Zurita, MD/Asst. Professor )
Study ID Numbers:   2005-0903
First Received:   May 19, 2006
Last Updated:   May 28, 2008
ClinicalTrials.gov Identifier:   NCT00329043
Health Authority:   United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer  
Adenocarcinoma of the Prostate  
Ductal Adenocarcinoma of the Prostate  
Hormonal Ablation  
Radical Prostatectomy  
LHRH Agonist
Lupron
Leuprolide
Sunitinib Malate
SU011248

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Sunitinib
Urogenital Neoplasms
Carcinoma, Ductal, Breast
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Reproductive Control Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Fertility Agents, Female
Therapeutic Uses
Fertility Agents
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 07, 2008




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