COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer

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. Identifier: NCT00182052
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 23, 2013
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital

Brief Summary:
The purpose of this study it to learn the effects (good or bad) that rosiglitazone has on patients and their prostate cancer. This study is going to look at what effects rosiglitazone has on prostate specific antigen (PSA) levels.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Prostate Cancer Drug: Rosiglitazone Other: Placebo Phase 3

Detailed Description:
  • Patients will be randomly assigned to initial treatment with either rosiglitazone or placebo orally twice daily, every day as long as there is no disease progression or serious side effects. Patients will be asked to complete a drug log to keep track of the medication.
  • Before treatment begins the following tests will be performed: physical exam; bone scan; blood work (including PSA level test) and a urine sample.
  • While on this study the following tests and procedures will be done once a month: review of side effects and routine blood tests (including PSA levels).
  • While on this study the following tests and procedures will be done on months 2 and 4: review of side effects; routine blood tests (including PSA levels) and urine tests.
  • If the patient's disease progressed the treatment code will be broken and if the patient was on placebo, they will have the option to begin taking rosiglitazone.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study
Study Start Date : September 2000
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Group 1 Drug: Rosiglitazone
Given orally twice daily. Participants may continue study treatment as long as their disease does not progress and they don't experience any serious side effects.
Other Name: Avandia

Placebo Comparator: Group 2 Other: Placebo
Given orally twice daily.

Primary Outcome Measures :
  1. To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Evaluate time to PSA progression as a measure of the activity of rosiglitazone. [ Time Frame: 3 years ]

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Biochemical disease progression following local therapy defined as three rises in PSA with each PSA determination at least 4 weeks apart and each PSA value > or = 0.2ng/ml
  • For men treated with radical prostatectomy, PSA > or = 2 ng/ml
  • For men treated with primary radiation therapy or post-prostatectomy radiation therapy, PSA > or = 2 ng/ml and > 150% post-radiation nadir
  • Not an appropriate candidate for salvage radiation therapy or salvage prostatectomy
  • Baseline PSADT < 24 months
  • CALGB performance status of 0,1 or 2

Exclusion Criteria:

  • Metastatic disease
  • Prior hormonal therapy for recurrent prostate cancer
  • Prior chemotherapy for prostate cancer
  • Current treatment with insulin or an oral hypoglycemic
  • History of treatment with thiazolidinediones
  • Radiation therapy within 6 months
  • SGOT > 1.5 x ULN
  • Fasting blood glucose < 60 mg/dl
  • NYHA Class 3 or 4 cardiac status

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 identifier (NCT number): NCT00182052

Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Layout table for investigator information
Principal Investigator: Matthew Smith, MD Massachusetts General Hospital
Layout table for additonal information
Responsible Party: Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital Identifier: NCT00182052    
Obsolete Identifiers: NCT00139412
Other Study ID Numbers: 00-100
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013
Keywords provided by Matthew R. Smith, MD, PhD, Massachusetts General Hospital:
androgen dependant prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hypoglycemic Agents
Physiological Effects of Drugs