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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182052
• Other study ID #: 00-100
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: May 22, 2013
• Start date: September 2000
• Est. completion date: August 2003

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00139412

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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:
• Placebo
Given orally twice daily.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith MR, Manola J, Kaufman DS, George D, Oh WK, Mueller E, Slovin S, Spiegelman B, Small E, Kantoff PW. Rosiglitazone versus placebo for men with prostate carcinoma and a rising serum prostate-specific antigen level after radical prostatectomy and/or radiation therapy. Cancer. 2004 Oct 1;101(7):1569-74. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.		3 years	No
Secondary	Evaluate time to PSA progression as a measure of the activity of rosiglitazone.		3 years	No