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Therapeutic Areas: Oncology | Nephrology | Urology | Family Medicine
Disease Category: Prostate Cancer
Location: United States, IL

Clinical Trial Details


Research Study Summary

SWOG S0925 Phase II Randomized Study of Combined Androgen Deprivation Comprising Bicalutamide and Goserelin or Leuprolide Acetate With Versus Without Cixutumumab in Patients With Newly Diagnosed Hormone-Sensitive Metastatic Prostate Cancer


To compare the undetectable PSA rate (< 0.2 ng/mL) in patients with newly diagnosed hormone-sensitive metastatic prostate cancer treated with combined androgen deprivation comprising bicalutamide and goserelin or leuprolide acetate with versus without cixutumumab.

Patient Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Metastatic disease as evidenced by soft tissue and/or bony metastases, including ≥ 1 of the following:
    1. Visceral disease (liver, lung, or other viscera)
    2. Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton
    3. PSA ≥ 5 ng/mL within 90 days before initiation of androgen-deprivation therapy (ADT)
    4. No known brain metastases
    5. Brain imaging studies not required for patients with no neurologic signs or symptoms

Patient Exclusion Criteria:

  • No prior cytotoxic chemotherapy for metastatic prostate cancer
  • Prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed
  • No prior treatment with agents that directly inhibit IGF or IGFR
  • No prior chimerized or murine monoclonal antibody therapy
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent treatment with any of the following:
    1. Chemotherapy
    2. Hormonal therapy (other than the LHRH agonist and oral anti-androgen)
    3. Radiotherapy
    4. Immunotherapy
    5. Any other anticancer therapy
    6. 5-alpha reductase inhibitors (e.g., finasteride or dutasteride)
    7. Ketoconazole
    8. Diethylstilbestrol/DES
    9. Other estrogen-based therapy

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Overall Status


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Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183156

Date Last Changed: July 17, 2013

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