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

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

April 27, 2012

Start Date ^ICMJE

September 2000

Primary Completion Date

August 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.

Change History

Complete list of historical versions of study NCT00182052 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Evaluate time to PSA progression as a measure of the activity of rosiglitazone.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Adenocarcinoma of the Prostate
Prostate Cancer

Intervention ^ICMJE

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
Other: Placebo
Given orally twice daily.

Study Arm (s)

Active Comparator: Group 1
Intervention: Drug: Rosiglitazone
Placebo Comparator: Group 2
Intervention: Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

100

Completion Date

Not Provided

Primary Completion Date

August 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00182052

Other Study ID Numbers ^ICMJE

00-100

Has Data Monitoring Committee

Not Provided

Responsible Party

Matthew R. Smith, MD, PhD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Dana-Farber Cancer Institute

Investigators ^ICMJE

Principal Investigator:

Matthew Smith, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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