Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	Dana-Farber Cancer Institute
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00182052

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 III

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

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 Smith, MD, PhD, 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:	December 28, 2007
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
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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 February 09, 2012