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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003645 |
Purpose
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: flutamide Drug: leuprolide acetate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase III Randomized Prospective Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence |
| Estimated Enrollment: | 496 |
| Study Start Date: | June 1999 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 496 patients (248 per treatment arm) will be accrued for this study within 3.5 years.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed organ confined stage I or II (T1-T2c) prostate cancer treated with radical prostatectomy and bilateral pelvic lymph node dissection
Must be at high risk of clinical or biochemical failure post-prostatectomy as defined by at least one of the following:
For patients with prior androgen ablation (up to 3 months):
For patients without prior androgen ablation:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Curtis A. Pettaway, MD | M.D. Anderson Cancer Center |
| Study Chair: | Michael O. Koch, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
| Study ID Numbers: | CDR0000066733, MDA-ID-97077, E-97077, NCI-T97-0069 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003645 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I prostate cancer stage II prostate cancer |
|
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Reproductive Control Agents Genital Diseases, Male |
Flutamide Pharmacologic Actions Androgen Antagonists Neoplasms Neoplasms by Site Leuprolide Fertility Agents, Female Therapeutic Uses Fertility Agents Prostatic Neoplasms |