Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00534196
- Lead Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Brief Summary
RATIONALE: Implant radiation therapy delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This clinical trial is studying the side effects and how well implant radiation therapy using radioactive iodine works in treating patients with localized prostate cancer.
- Detailed Description
OBJECTIVES:
* To determine the efficacy of permanent brachytherapy with iodine I 125 seeds in patients with localized prostate cancer.
* To determine the safety of this therapy in these patients.
OUTLINE: This is a multicenter study.
Patients undergo permanent brachytherapy seed implantation comprised of iodine I 125 into the prostate. Some patients may receive combination treatment (e.g., external beam radiation therapy (EBRT) or hormone therapy in addition to brachytherapy).
Quality of life and the International Prostate Symptom Score (IPSS) is assessed and compared.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6927
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PSA relapse-free survival 5 years Defined as the duration from enrollment to the date of biological relapse, which was defined as three consecutive prostate specific antigen (PSA) rises in the reflex range of 1.0 ng/ml or greater, and the date of failure was the midpoint between the first day that showed PSA levels 1.0 ng/ml or greater and the last day in which the level was below 1.0 ng/ml.
- Secondary Outcome Measures
Name Time Method Adverse events 36 months Types and severities of adverse events from date of starting protocol treatment until the first 30 months after date of finishing the treatment are evaluated in the most serious adverse events of each reporting period according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.
Progression free survival (PFS) 5 years Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS).
Quality of life Baseline, Month 3, 12, 24 and 36 The Japanese version of the SF-8 (the MOS 8 item Short-Form Health Survey), the Japanese version of the Extended Prostate Cancer Index Composite (EPIC) are used for characterizing Longitudinal changes in health-related quality of life (HRQOL), and the EPIC was used to investigate disease-specific quality of life (disease-specific QOL). Patients enrolled between July 2005 - June 2007 will be evaluated.
IPSS score Baseline, Month 3, 12, 24 and 36 Evaluated by International Prostate Syndrom Score (IPSS)
Trial Locations
- Locations (31)
Fujita Health University
🇯🇵Toyoake, Aichi, Japan
Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
Isesaki Municipal Hospital
🇯🇵Isesaki, Gunma, Japan
Gunma University Graduate School of Medicine
🇯🇵Maebashi, Gunma, Japan
Kurosawa Hospital
🇯🇵Takasaki, Gunma, Japan
Sapporo Medical University
🇯🇵Sapporo, Hokkaido, Japan
Translational Research Informatics Center
🇯🇵Kobe, Hyogo, Japan
Ibaraki Prefectural Central Hospital
🇯🇵Kasama, Ibaraki, Japan
Kagawa University Hospital
🇯🇵Miki, Kagawa, Japan
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