Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Prednisone; Androgen deprivation therapy (ADT)
Intervention description: Participants will receive abiraterone acetate 1000 mg (4*250 mg tablets) orally once daily until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.; Participants will prednisone 5 mg orally once daily from Day 1 of Cycle 1 and continues until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.; Participants will remain on a stable regimen of ADT, that is, luteinizing hormone-releasing hormone (LHRH) agonists including leuprolide acetate and goserelin acetate as per Investigator's discretion.
Intervention MeSH terms: Prednisone; Abiraterone Acetate; Androgens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostatic neoplasms; Diethylstilbestrol therapy; Abiraterone acetate; Prednisone; Androgen deprivation therapy

Summary:

      The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen
      (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer
      cells from one part of the body to another) castration (any action, surgical, chemical, or
      otherwise, by which a male loses the functions of the testes) resistant prostate cancer
      (cancer in prostrate; a gland that makes fluid that aids movement of sperm) (mCRPC),
      chemo-naive (treatment of cancer is not done using drugs), who received a prior
      diethylstilbestrol therapy (DES).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate without
             neuroendocrine differentiation or small cell histology

          -  Prior therapy with diethylstilbestrol (DES) for castration resistant prostate cancer.
             Participants should demonstrate evidence of progression on DES or evidence of grades
             3/4 toxicities on DES

          -  Metastatic disease documented by positive bone scan or metastatic lesions on
             computerized tomography (CT) or magnetic resonance imaging (MRI)

          -  May have received prior androgen blockage (bicalutamide or flutamide) but must have
             been discontinued for least 28 days

          -  Ongoing androgen deprivation therapy (ADT) (luteinizing hormone-releasing hormone
             [LHRH] agonist or orchiectomy), with serum testosterone level of less than 50 nanogram
             per deciliter (1.7 nanomole per liter) and eligible participants must maintain ADT

        Exclusion Criteria:

          -  Active infection or other medical condition that would make prednisone use
             contraindicated

          -  Any chronic medical condition requiring a higher systemic dose of corticosteroid than
             5 milligram (mg) prednisone per day

          -  Pathological finding consistent with small cell carcinoma of the prostate

          -  Known brain metastasis

          -  Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of
             metastatic castration-resistant prostate cancer (mCRPC)