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Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer
Overall Recruitment Status: Active, enrollment completed
 
Official Title
Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) With a GNRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT With a GNRH Agonist and TAK-700 For Men With High Risk Prostate Cancer
 
Region Sponsors
California - Northern
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
 
Acronym KP IRB No.
CN-12SSeaw-04-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Prostate Cancer
 
Purpose
This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.
 
Detailed Description
 
Gender Age Limit
Male
 
Inclusion Criteria
  • Height, weight, Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 8.0 g/dL (The use of transfusion or other intervention to achieve Hgb >= 8.0 g/dL is acceptable)
  • Serum creatinine < 2.0 mg/dL
  • Creatinine clearance > 40 mL/minute
  • Bilirubin < 1.5 x upper limit of normal (ULN)
  • Alanine aminotranserase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
 
Exclusion Criteria
  • Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years
  • Known hypersensitivity to TAK-700 or related compounds
  • History of adrenal insufficiency
  • New York Heart Association Class III or IV heart failure
  • ECG abnormalities of Q-wave infarction, unless identified 6 or more months prior to screening, or corrected QT (QTc) interval > 460 msec
  • Prior allergic reaction to the drugs involved in this protocol
  • Cushing syndrome
  • Severe chronic renal disease or chronic liver disease

 
Keywords and/or Specific Medical Conditions
  • adenocarcinoma of the prostate
  • Luteolytic Agents
  • Androgen Antagonists
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents
  • Neoplasms
  • Antineoplastic Agents, Hormonal
  • Neoplasms by Site
  • Bicalutamide
  • Pharmacologic Actions
  • Buserelin
  • Physiological Effects of Drugs
  • Contraceptive Agents
  • Prostatic Diseases
  • Contraceptive Agents, Female
  • Prostatic Neoplasms
  • Deslorelin
  • Reproductive Control Agents
  • Enzyme Inhibitors
  • stage I prostate cancer
  • Fertility Agents
  • stage IIA prostate cancer
  • Fertility Agents, Female
  • stage IIB prostate cancer
  • Flutamide
  • stage III prostate cancer
  • Genital Diseases, Male
  • stage IV prostate cancer
  • Genital Neoplasms, Male
  • Therapeutic Uses
  • Goserelin
  • Triptorelin
  • Hormone Antagonists
  • Urogenital Neoplasms
  • Hormones, Hormone Substitutes, and Hormone Antagonists
  • Oncology (Adult)
  • Leuprolide
 
KP Clinical Facility
  • Central Valley-Modesto
  • Santa Clara Medical Center-Homestead
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Samantha Seaward, MD
Contact Information:
- Vanessa Sheldon, RN
-(209) 735-4161
-Central Valley-Modesto
- Beatriz Jio, RN
-(408) 851-4315
-Santa Clara Medical Center-Homestead


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