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Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00329043
Recruitment Status : Active, not recruiting
First Posted : May 24, 2006
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: LHRH Agonist Drug: Sunitinib Malate Procedure: Radical Prostatectomy Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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:
  • Lupron
  • Leuprolide
Drug: Sunitinib Malate
25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles.
Other Name: SU011248
Procedure: Radical Prostatectomy
Radical prostatectomy after completion of Sunitinib and LHRH agonist.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

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


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer
Investigators
Principal Investigator: Amado Zurita, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00329043     History of Changes
Other Study ID Numbers: 2005-0903
NCI-2012-01364 ( Registry Identifier: NCI CTRP )
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sunitinib
Leuprolide
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal