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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00182052
First received: September 14, 2005
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Adenocarcinoma of the Prostate
Prostate Cancer
 Drug: Rosiglitazone
Other: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate time to PSA progression as a measure of the activity of rosiglitazone. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2000
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182052

Locations
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
Investigators
Principal Investigator: Matthew Smith, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00182052     History of Changes
Obsolete Identifiers: NCT00139412
Other Study ID Numbers: 00-100
Study First Received: September 14, 2005
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
rosiglitazone
Avandia
androgen dependant prostate cancer

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
Rosiglitazone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 19, 2013