Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00091390|
Recruitment Status : Completed
First Posted : September 9, 2004
Results First Posted : November 14, 2014
Last Update Posted : June 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: HDR brachytherapy boost Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||December 2016|
Experimental: EBRT and HDR brachytherapy boost
External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
Radiation: HDR brachytherapy boost
Brachytherapy could be performed before or after the external beam radiotherapy. The overall treatment course (external beam radiotherapy and brachytherapy) was limited to no longer than 8 weeks. 19 Gy in two fractions was to be given only to the clinical target volume (CTV). The first HDR treatment was to be delivered on the day of the catheter placement. The second treatment was to be delivered within 24 hours after the first treatment, but no less than 6 hours between implants.Radiation: radiation therapy
1.8 Gy given five times per week for a total dose of 45 Gy.
- Late Severe Genitourinary (GU) and Gastrointestinal (GI) Toxicity at 18 Months [ Time Frame: Beginning nine months after start of treatment. ]Eighteen-month rate of late severe (grade 3-5) genitourinary (GU) and gastrointestinal (GI) toxicity, defined as starting more than 9 months from treatment start, and graded by CTCAE v3.0
- Acute Severe GU and GI Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Within 9 Months of Starting Treatment [ Time Frame: From registration until 9 months from the start of treatment ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|