Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate|
- Late severe genitourinary (GU) and gastrointestinal (GI) toxicity as measured by CTCAE v3.0 more than 9 months after starting treatment [ Time Frame: From registration until 9 months from the start of treatment ] [ Designated as safety issue: Yes ]
- Acute severe GU and GI toxicity as measured by CTCAE v3.0 within 9 months of starting treatment [ Time Frame: From registration until 9 months from the start of treatment ] [ Designated as safety issue: Yes ]
- Biochemical failure [ Time Frame: From registration to the date of biochemical failure or last follow-up. Analysis occurs after each patient has had 3 years of follow-up. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From registration to the date of death or last follow-up. Analysis occurs after each patient has had 3 years of follow-up. ] [ Designated as safety issue: No ]
- Disease-specific survival [ Time Frame: From registration to the date of death due to prostate cancer or other disease related cause. Analysis occurs after each patient has had 3 years of follow-up. ] [ Designated as safety issue: No ]
- Clinical progression including local/regional and distant relapse [ Time Frame: From registration to the date of local/regional progression or distant relapse, or last follow-up. Analysis occurs after each patient has had 3 years of follow-up. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Experimental: EBRT and HDR brachytherapy boost
External beam radiation therapy (EBRT), 45 Gy and High dose rate (HDR) brachytherapy boost, 19 Gy in 2 fractions
|Radiation: brachytherapy Radiation: radiation therapy|
- Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate.
- Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen.
- Determine freedom from biochemical failure in patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Determine disease-specific survival of patients treated with this regimen.
- Determine clinical relapse (local and/or distant) in patients treated with this regimen.
- Develop a quality assurance process for high-dose rate prostate brachytherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy).
Patients undergo external beam radiotherapy over approximately 15 minutes once daily 5 days a week for 5 weeks. Patients also receive two fractions (within a 24-hour period) of high-dose rate brachytherapy (delivered through an implant inserted into the prostate) over approximately 5-30 minutes either before or after external beam radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091390
|United States, California|
|Providence Saint Joseph Medical Center - Burbank|
|Burbank, California, United States, 91505|
|Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital|
|Inglewood, California, United States, 90301|
|Radiological Associates of Sacramento Medical Group, Incorporated|
|Sacramento, California, United States, 95815|
|United States, Colorado|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center|
|Boca Raton, Florida, United States, 33486|
|United States, Illinois|
|OSF St. Francis Medical Center|
|Peoria, Illinois, United States, 61637|
|United States, Maine|
|Maine Center for Cancer Medicine and Blood Disorders - Scarborough|
|Scarborough, Maine, United States, 04074|
|United States, Michigan|
|William Beaumont Hospital - Royal Oak Campus|
|Royal Oak, Michigan, United States, 48073|
|United States, New Jersey|
|Newark Beth Israel Medical Center|
|Newark, New Jersey, United States, 07112|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|United States, Vermont|
|Fletcher Allen Health Care - University Health Center Campus|
|Burlington, Vermont, United States, 05401|
|United States, Wisconsin|
|Waukesha Memorial Hospital Regional Cancer Center|
|Waukesha, Wisconsin, United States, 53188|
|Study Chair:||I-Chow J. Hsu, MD||University of California, San Francisco|