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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 S1014 Phase II Study of Abiraterone Acetate in Patients With Metastatic Prostate Cancer and a Sub-Optimal Prostate-Specific Antigen Following Initial Androgen-Deprivation Therapy


To assess the rate of achieving a prostate-specific antigen (PSA) of = 0.2 ng/mL with abiraterone acetate therapy in men with metastatic prostate cancer with a sub-optimal response to androgen-deprivation therapy (ADT).

Patient Inclusion Criteria:

  • Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate
  • Metastatic (M1) disease as evidenced by soft tissue and/or bony metastases at the time of initiation of androgen-deprivation therapy (ADT)
  • Must have at least one of the following:
    1. Visceral disease (liver, lung, 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. Distant lymph node disease (e.g., above the aortic bifurcation, etc.)
    4. Patients must be receiving ADT (e.g., gonadotropin-releasing hormone (GNRH) antagonist, with or without antiandrogen) prior to entering this study
    5. Degarelix, a FDA-approved is an acceptable form of ADT

Patient Exclusion Criteria:

  • No small cell or neuroendocrine prostate cancer
  • No patients with a rising PSA
  • No patients with radiographic progression when compared to available imaging studies performed prior to starting the GNRH agonist/antagonist therapy
  • No patients with a history of brain metastases or who currently have treated or untreated brain metastases
  • Patients with clinical evidence of brain metastases must have a brain CT scan or MRI negative for metastatic disease within 56 days prior to registration
  • At least 6 weeks since prior and no concurrent finasteride or dutasteride
  • At least 28 days since prior radiotherapy or surgery and recovered
  • At least 14 days since prior investigational products
  • At least 4 weeks since prior flutamide

To Learn more






Overall Status


Facility Type



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: 183158

Date Last Changed: July 17, 2013

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