Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00032006 |
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining hormone therapy with internal radiation may be effective in treating locally recurrent prostate cancer.
PURPOSE: Phase II trial to study the effectiveness of hormone therapy followed by internal radiation in treating patients who have locally recurrent prostate cancer following external-beam radiation therapy.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: bicalutamide Drug: flutamide Drug: goserelin Drug: iodine I 125 Drug: leuprolide acetate Drug: palladium Pd 103 Procedure: brachytherapy Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy |
Study Start Date: | February 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive androgen suppression comprising goserelin subcutaneously (as either 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection) OR leuprolide intramuscularly (as 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection or 1 four-month depot injection) AND oral flutamide 3 times daily for 112 days OR oral bicalutamide once daily for 112 days.
Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy.
Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3 months for 1 year, and then every 6 months for 2 years.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 83-166 patients (83 per cohort) will be accrued for this study within 1.5-3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed locally recurrent or persistent prostate adenocarcinoma
N0 and M0 (at time of initial diagnosis and at time of local recurrence)
Must have had 1 of the following disease characteristics prior to external beam radiotherapy:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Arizona | |
CCOP - Scottsdale Oncology Program | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
United States, Iowa | |
CCOP - Iowa Oncology Research Association | |
Des Moines, Iowa, United States, 50309-1016 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Nebraska | |
CCOP - Missouri Valley Cancer Consortium | |
Omaha, Nebraska, United States, 68106 | |
United States, Pennsylvania | |
Allegheny General Hospital | |
Pittsburgh, Pennsylvania, United States, 15212-4772 | |
United States, Wisconsin | |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
Green Bay, Wisconsin, United States, 54301 |
Study Chair: | Thomas M. Pisansky, MD | Mayo Clinic |
Investigator: | Robert M. Arusell, MD | Roger Maris Cancer Center at MeritCare Hospital |
Study ID Numbers: | CDR0000069248, NCCTG-N0052 |
Study First Received: | March 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00032006 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer recurrent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Leuprolide Goserelin Bicalutamide Iodine |
Urogenital Neoplasms Flutamide Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Pharmacologic Actions |
Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Fertility Agents, Female Fertility Agents |