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Mifepristone (RU-486) in Androgen Independent Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Georgetown University
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00140478
First received: August 30, 2005
Last updated: December 7, 2009
Last verified: December 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer [ Time Frame: TBD ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140478

Locations
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
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

No publications provided

Responsible Party: Mary-Ellen Taplin, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00140478     History of Changes
Other Study ID Numbers: 04-249
Study First Received: August 30, 2005
Last Updated: December 7, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013