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Trilostane for Androgen-Independent Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181597
First Posted: September 16, 2005
Last Update Posted: December 3, 2013
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.
Information provided by:
Sanofi
  Purpose
The main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer.

Condition Intervention Phase
Prostate Cancer Prostate Adenocarcinoma Drug: Trilostane Drug: Hydrocortisone 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 Trilostane for Androgen-Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • activity of trilostane in men with androgen-independent prostate cancer. [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • serum levels of gonadal and adrenal steroids [ Time Frame: 4 years ]

Enrollment: 24
Study Start Date: March 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Trilostane
    Taken orally once a day for three days then twice daily thereafter.
    Drug: Hydrocortisone
    Taken orally with trilostane.
Detailed Description:
  • Patients will take trilostane orally once a day for three days, then twice a day thereafter.
  • Patients will complete a daily drug log recording the date, time and number of capsules taken.
  • Trilostane may moderately decrease the production of steroids by the adrenal glands. In order to prevent any symptoms related to decreased steroid production, patients will also take hydrocortisone at the same time as the trilostane.
  • While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood. On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels. Blood pressure and pulse rate will also be taken every 4 weeks.
  • Depending upon disease status, radiological testing (CT scan, x-rays, and/or bone scan) may be repeated every 12 weeks.
  • Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma
  • Disease progression despite androgen depravation therapy and antiandrogen withdrawal
  • Progressive measurable disease or bone scan progression or PSA progression
  • Serum total testosterone < 50ng/ml
  • Creatinine < 2.0 mg/dl
  • ALT < 2 x ULN
  • CALGB performance status of 0,1, or 2

Exclusion Criteria:

  • Radiation therapy within 4 weeks
  • Antiandrogen within 8 weeks
  • Other secondary hormonal therapy or investigational agents within 4 weeks
  • Prior chemotherapy for androgen-independent prostate cancer
  • History of adrenal insufficiency
  • Known brain metastases
  • Severe liver or renal disease
  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): NCT00181597


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Medical Monitor, Genzyme
ClinicalTrials.gov Identifier: NCT00181597     History of Changes
Other Study ID Numbers: 04-037
First Submitted: September 9, 2005
First Posted: September 16, 2005
Last Update Posted: December 3, 2013
Last Verified: December 2013

Keywords provided by Sanofi:
Trilostane
Androgen-independent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hydrocortisone 17-butyrate 21-propionate
Adenocarcinoma
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Androgens
Dihydrotestosterone
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Trilostane
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action