Trial Information

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

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
Email: janeen.bazan@shermanhospital.org

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Research Center Information: Sherman Health

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