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Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer

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. Identifier: NCT00631527
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : January 29, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Leuprolide Drug: Goserelin Drug: Sunitinib Malate Drug: Casodex Radiation: Radiation Therapy (RT) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer
Study Start Date : February 2008
Actual Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sunitinib Malate, Hormone Ablation + RT
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
Drug: Leuprolide
Injections given through a needle in the muscle every 3 months.
Other Name: Lupron

Drug: Goserelin
Subcutaneous injections given once every 3 months.
Other Name: Zoladex

Drug: Sunitinib Malate
Starting dose of 12.5 mg by mouth daily for 4 weeks
Other Names:
  • SU011248
  • Sutent

Drug: Casodex
Once a day by mouth for 2 weeks.
Other Name: Bicalutamide

Radiation: Radiation Therapy (RT)
Radiation treatment once daily over a period of 8 weeks.
Other Name: Radiotherapy

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT) [ Time Frame: 8 weeks ]

    DLT defined as inability to complete the schedule course of radiation therapy for toxicity of any grade. If < 2 patients in initial cohort of 6 experience DLT then a subsequent dose-level cohort initiated. If 2 or more patients in a cohort experience DLT then further accrual to that cohort curtailed and no higher dose level examined. Maximum tolerated dose (MTD) for oral sunitinib in combination with radiation and hormone ablation defined as highest dose level in which 6 patients have been treated with 2 or less than 2 instances of DLT.

    DLT for the purposes of dose-escalation or calculation of the maximum tolerated dose (MTD) defined as any medically unmanageable Grade 2 toxicity or any Grade 3 or 4 toxicity experienced during the 8 week period of combined hormone ablation, Sunitinib, and radiation therapy.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adenocarcinoma of the prostate with the following high-risk features are eligible: clinical T2c, clinical or pathological T3 or T4 disease OR Gleason 8-10 disease OR PSA > 20ng/ml.
  2. Patients must have no evidence of metastatic disease by clinical and radiological staging including Chest X-ray, Bone scan and CT Scan of the Abdomen and Pelvis.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  4. Calculated Creatinine clearance > 35cc/min, Absolute neutrophil count > 1,500/mm^3, Platelets >/= 100,000/mm^3, AST/ALT < 2.5 x upper normal limit (UNL), Total bilirubin within normal limits (WNL).
  5. No standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.
  6. Patients must be at least 18 years of age
  7. Patients may have had up to 8 weeks of hormonal therapy defined as luteinizing-hormone releasing hormone or other medical castration therapy prior to registration.

Exclusion Criteria:

  1. Prior VEGFR/PDGFR inhibitor or other investigational therapy.
  2. Inability to take oral medication
  3. Chronically uncontrolled hypertension, defined conventionally as consistent/repeated systolic pressures above 140 mmHg or diastolic pressures above 90 mmHg despite anti-hypertensive therapy. This may be established with home BP readings. There is no criterion related to a specific BP result required for eligibility, nor are acute BP elevations that are related to iatrogenic causes, acute pain, or other transient reversible causes considered an exclusion criteria. The intent is to exclude patients with chronically uncontrolled hypertension that might be further exacerbated by Sunitinib.
  4. Left Ventricular Ejection Fraction </= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.
  5. Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis.

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 identifier (NCT number): NCT00631527

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Paul Corn, MD, PHD M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00631527    
Other Study ID Numbers: 2006-0684
NCI-2010-01524 ( Registry Identifier: NCI CTRP )
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: January 29, 2015
Last Verified: January 2015
Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Radiation Therapy
Hormone Ablation
Sunitinib Malate
Angiogenesis inhibitor
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists