Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate Cancer (TARGET)
Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma
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
Sites / Locations
- UCLA / Jonsson Comprehensive Cancer Center
- UCSF Medical Center-Parnassus
- University of Chicago Comprehensive Cancer Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Dana-Farber Cancer Institute
- University of Michigan Comprehensive Cancer Center
- Wayne State University/Karmanos Cancer Institute
- Mayo Clinic
- UMDNJ - New Jersey Medical School
- Memorial Sloan-Kettering Cancer Center
- Duke University Medical Center
- Oregon Health and Science University
- M D Anderson Cancer Center
- University of Washington Medical Center
- University of Wisconsin Hospital and Clinics
Arms of the Study
Arm 1
Experimental
Treatment (Antihormone therapy and enzyme inhibitor therapy)
Patients receive bicalutamide PO QD for 1 month and leuprolide acetate IM or goserelin acetate SC once a month until surgery. Patients also receive vorinostat PO QD beginning on the first day of androgen depletion therapy and continuing for up to 8 weeks or until the day of surgery. Patients then undergo an open or laparoscopic radical prostatectomy. Patients with positive surgical margins undergo immediate adjuvant external beam radiotherapy to the prostatic fossa, based on the judgment of the treating physician.