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

Clinical Trial Details

Overview

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

Purpose

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
Phase

2

Gender

Male

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

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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