Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate Cancer
Condition: Prostate Adenocarcinoma; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Bicalutamide; Goserelin Acetate; Laboratory Biomarker Analysis; Leuprolide Acetate; Therapeutic Conventional Surgery; Vorinostat
Intervention description: Given PO; Given SC; Correlative studies; Given IM; Undergo radical prostatectomy; Given PO
Intervention MeSH terms: Vorinostat; Leuprolide; Goserelin; Bicalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well androgen deprivation therapy and vorinostat followed by
      radical prostatectomy works in treating patients with prostate cancer that has not spread to
      other parts of the body. Androgens can cause the growth of prostate cancer cells. Antihormone
      therapy, such as bicalutamide, goserelin acetate, and leuprolide acetate, may lessen the
      amount of androgens made by the body. Vorinostat may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth. Giving androgen deprivation therapy and
      vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue
      that needs to be removed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic documentation of prostatic adenocarcinoma in 3 or more biopsy cores, of
             which at least 1 core demonstrates > 30% involvement with tumor; confirmation of
             localized disease by magnetic resonance imaging (MRI) with endorectal probe if
             available

          -  No evidence of distant disease on a:

               -  Computed tomography (CT) or MRI of the abdomen and pelvis

               -  Radionuclide bone scan (with plain film or MRI confirmation as clinically
                  indicated)

          -  Appropriate candidate for radical prostatectomy

               -  Adequate cardiac function (evidence of cardiac disease should be evaluated to
                  determine appropriateness of patient as a surgical candidate)

               -  Candidates may have a history of deep vein thrombosis, pulmonary embolism, and/or
                  cerebrovascular accident, or require concomitant systemic anticoagulation, if
                  otherwise deemed to be suitable for radical prostatectomy

          -  White blood cell (WBC) > 3000/uL

          -  Platelets > 150,000/uL

          -  Creatinine < 2 mg/dL

          -  Serum PSA < 100 ng/mL

          -  Bilirubin < 1.5 X ULN (institutional upper limits of normal)

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2 X ULN

          -  Karnofsky performance status > 70%

          -  Willingness to undergo pretreatment transrectal ultrasound-guided prostate needle
             biopsy (optional)

          -  Willingness to use adequate contraceptive methods during study therapy and for at
             least 3 months after completion of therapy

          -  Ability to understand and willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Evidence of small-cell, transitional-cell, or neuroendocrine pathologic features

          -  Prior hormonal therapy with (e.g. 5-alpha-reductase inhibitors, gonadotropin hormone
             releasing analogs, steroids, megestrol acetate, or nonstudy-related antiandrogens),
             chemotherapy, or herbal medications administered with the intent to treat the
             patient's malignancy

               -  Patients on valproic acid (a histone-deacetylase inhibitor) to treat prostate
                  cancer are not eligible

          -  History of allergic reactions attributed to compounds of similar chemical or
             biological composition to vorinostat

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situation that would compromise compliance
             with study requirements

          -  Currently active secondary malignancy (as determined by the treating physician) other
             than non-melanoma skin cancer