Androgen Deprivation Therapy and Vorinostat Followed by Radical Prostatectomy in Treating Patients With Localized Prostate Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00589472
Phase
PHASE2
Status
Completed

Conditions

  • Prostate Adenocarcinoma
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bicalutamide — DRUG
    Given PO
  • Goserelin Acetate — DRUG
    Given SC
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Leuprolide Acetate — DRUG
    Given IM
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo radical prostatectomy
  • Vorinostat — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Nov 30, 2007
Status verified
Sep 2017
Primary completion
Jun 30, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Pathologic Complete Response at the Time of Surgery [ Time Frame: At 12 weeks ]

Locations (15)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-
UCSF Medical Center-ParnassusSan FranciscoCalifornia94143-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Mayo ClinicRochesterMinnesota55905-
UMDNJ - New Jersey Medical SchoolNewarkNew Jersey07103-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
Oregon Health and Science UniversityPortlandOregon97239-
M D Anderson Cancer CenterHoustonTexas77030-
University of Washington Medical CenterSeattleWashington98195-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Los Angeles, CA

By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CAUCSF Medical Center-Parnassus· San Francisco, CAUniversity of Chicago Comprehensive Cancer Center· Chicago, ILJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDDana-Farber Cancer Institute· Boston, MAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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