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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.
Study Type Phase
Clinical Trial Phase III
Study Population Description
Prostate Cancer
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
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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