Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone Acetate; Prednisone; LHRHa
Intervention description: 1000 mg oral daily for 3 months followed by a prostatectomy.; 5 mg orally daily.; LHRH analogue (either leuprolide or goserelin): Leuprolide is an intramuscular injection, and goserelin subcutaneous (under skin) of abdomen, given either 1 injection every 3 months or 1 injection each month for 3 months.
Intervention MeSH terms: Prednisone; Leuprolide; Goserelin; Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoadjuvant Prostate Cancer; Abiraterone Acetate; LHRHa; high risk prostate cancer; Radical prostatectomy; Prednisone; Luteinizing Hormone-Releasing Hormone; LHRH analogue

Summary:

      The goal of this clinical research study is to find out how treatment with abiraterone
      acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH)
      analogue changes the tumor in comparison to treatment with an LHRH analogue alone.

      Objectives:

      Primary Objective:

      To assess the difference in pathologic stage < pT2 between Group A and Group B.

      Secondary Objective:

        -  To assess and compare the changes in levels of androgens (pre, during, and post
           treatment) in the serum, primary tumor microenvironment and bone marrow between Group A
           and Group B.

        -  To assess changes in biomarkers related to androgen signaling and other cancer-related
           pathways between Group A and Group B.

        -  To assess the difference in rate of positive surgical margins between Group A and Group
           B.

        -  To assess the safety profile of abiraterone acetate and low dose prednisone in a
           preoperative setting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological proof of prostatic adenocarcinoma via a minimum of 6 core biopsy samples

          2. Clinical stage T1c or T2 with high-grade disease (Gleason's 8-10) on initial biopsy,
             or clinical stage T2b-T2c with Gleason's grade >/= 7 and PSA > 10ng/ml.

          3. No evidence of metastatic disease as determined by CT scans and bone scans.

          4. Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1

          5. Patients should have adequate bone marrow function defined as an absolute peripheral
             granulocyte count (ANC) > 1,500 and platelet count of > 100,000.

          6. Normal pituitary and adrenal function

          7. Patients should be deemed to be candidates for radical prostatectomy.

        Exclusion Criteria:

          1. Histological variants in the primary tumor (histological variants other than
             adenocarcinoma); neuroendocrine tumor

          2. Serious or uncontrolled co-existent non-malignant disease, including active and
             uncontrolled infection

          3. Uncontrolled hypertension

          4. Abnormal Liver function

          5. Active or symptomatic viral hepatitis or chronic liver disease

          6. Clinically significant heart disease

          7. Other active malignancy

          8. History of gastrointestinal disorders (medical disorders or extensive surgery) which
             may interfere with the absorption of the study drug

          9. Previous treatment with abiraterone acetate

         10. Patients who are not appropriate surgical candidates for radical prostatectomy

         11. Prior chemotherapy or radiation therapy for prostate cancer.

         12. Condition or situation which, in the investigator's opinion, may put the patient at
             significant risk, may confound the study results, or may interfere significantly with
             patient's participation in the study

        Note: There are additional inclusion and exclusion criteria. The study center will
        determine if you meet all of the criteria.