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Mifepristone (RU-486) in Androgen Independent Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140478
First Posted: September 1, 2005
Last Update Posted: December 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Georgetown University
Information provided by:
Dana-Farber Cancer Institute
  Purpose
The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.

Condition Intervention Phase
Prostate Cancer Adenocarcinoma of Prostate Drug: Mifepristone Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer

Estimated Enrollment: 48
Study Start Date: February 2005
Study Completion Date: January 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mifepristone
    200mg orally once daily
    Other Name: RU-486
Detailed Description:

Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.

At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.

After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic documentation of adenocarcinoma of the prostate
  • Bone metastasis(es) by bone scan or cat scan
  • Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
  • One prior chemotherapy treatment is allowed.
  • > 3 weeks since major surgery
  • > 4 weeks since radiotherapy
  • > 8 weeks since prior strontium-89 or samarium 153
  • ECOG performance status 0 or 1
  • Absolute neutrophil count (ANC) > 1,500/ul
  • Platelets > 100,000/ul
  • Bilirubin < 1.5 x upper limit of normal (ULN)
  • AST or ALT < 3 x ULN
  • Creatinine < 1.5 x ULN
  • Electrolytes within 10% of normal range
  • Serum testosterone < 50ng/dL
  • Prostate-specific antigen (PSA) > 5.0ng/ml

Exclusion Criteria:

  • Concomitant therapy with corticosteroids
  • Chemotherapy within 28 days
  • Currently active second malignancy other than non-melanoma skin cancer
  • Baseline adrenal insufficiency requiring long-term steroids
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140478


Locations
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Georgetown University
Investigators
Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Mary-Ellen Taplin, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00140478     History of Changes
Other Study ID Numbers: 04-249
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: December 9, 2009
Last Verified: December 2009

Keywords provided by Dana-Farber Cancer Institute:
Androgen Independent Prostate Cancer
Prostate Cancer
Mifepristone
RU-486

Additional relevant MeSH terms:
Genital Diseases, Male
Prostatic Diseases
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Androgens
Mifepristone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents