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


Phase 3
18 Years
N/A
Not Enrolling
Male
Adenocarcinoma of the Prostate, Prostate Cancer

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Matthew Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

00-100

NCT ID:

NCT00182052

Start Date:

September 2000

Completion Date:

August 2003

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Prostate Cancer
  • rosiglitazone
  • Avandia
  • androgen dependant prostate cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617