Clinical trial NCT00182052: Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
Official title: Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adenocarcinoma of the Prostate
Prostate Cancer
Keywords: rosiglitazone
Avandia
androgen dependant prostate cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2005-09-16
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.
timeFrame: 3 years
Secondary outcomes:
measure: Evaluate time to PSA progression as a measure of the activity of rosiglitazone.
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Matthew Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/cncr.20493.