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.
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.
Study Type
OBSERVATIONAL
Enrollment
6,927
Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.
PSA relapse-free survival
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.
Time frame: 5 years
Progression free survival (PFS)
Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS).
Time frame: 5 years
Quality of life
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.
Time frame: Baseline, Month 3, 12, 24 and 36
IPSS score
Evaluated by International Prostate Syndrom Score (IPSS)
Time frame: Baseline, Month 3, 12, 24 and 36
Adverse events
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.
Time frame: 36 months
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Fujita Health University
Toyoake, Aichi-ken, Japan
Shikoku Cancer Center
Matsuyama, Ehime, Japan
Ehime University Hospital
Tōon, 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, Hyōgo, Japan
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, Japan
Kagawa University Hospital
Hiragi, Kagawa-ken, Japan
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