Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer (J-POPS)
|ClinicalTrials.gov Identifier: NCT00534196|
Recruitment Status : Active, not recruiting
First Posted : September 24, 2007
Last Update Posted : June 7, 2017
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Radiation: Permanent iodine-125 (Brachytherapy)|
- 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|
|Actual Enrollment :||6927 participants|
|Official Title:||Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS]|
|Study Start Date :||July 2005|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
Group under operation of brachytherapy
Patients with histologically confirmed adenocarcinoma of the prostate and who are planning to undergo brachytherapy with PI (permanent iodine) or combination of PI with other tratement.
Radiation: Permanent iodine-125 (Brachytherapy)
Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.
- PSA relapse-free survival [ Time Frame: 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.
- Progression free survival (PFS) [ Time Frame: 5 years ]Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS).
- Quality of life [ Time Frame: 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 [ Time Frame: Baseline, Month 3, 12, 24 and 36 ]Evaluated by International Prostate Syndrom Score (IPSS)
- Adverse events [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534196
|Fujita Health University|
|Toyoake, Aichi, Japan, 470-11|
|Shikoku Cancer Center|
|Matsuyama, Ehime, Japan, 790-0007|
|Ehime University Hospital|
|Toon, Ehime, Japan, 791-0295|
|Isesaki Municipal Hospital|
|Isesaki, Gunma, Japan, 872-0817|
|Gunma University Graduate School of Medicine|
|Maebashi, Gunma, Japan, 371-8511|
|Takasaki, Gunma, Japan, 370-0852|
|Sapporo Medical University|
|Sapporo, Hokkaido, Japan, 060-8556|
|Translational Research Informatics Center|
|Kobe, Hyogo, Japan, 650-0047|
|Ibaraki Prefectural Central Hospital|
|Kasama, Ibaraki, Japan, 309-1793|
|Kagawa University Hospital|
|Miki, Kagawa, Japan, 761-0793|
|Osaka University Graduate School of Medicine|
|Suita, Osaka, Japan, 565-0871|
|National Hospital Organization - Saitama National Hospital|
|Wako, Saitama, Japan, 351-0102|
|Shiga University of Medical Science|
|Otsu, Shiga, Japan, 520-21|
|Shimane University Hospital|
|Izumo, Shimane, Japan, 693-8501|
|University of Fukui Hospital|
|Fukui, Japan, 910-1193|
|Fukuoka, Japan, 810-8539|
|Kyushu University Hospital|
|Fukuoka, Japan, 812-8582|
|Gifu University Graduate School of Medicine|
|Gifu, Japan, 500-8705|
|Gunma Cancer Center|
|Gunma, Japan, 373-0828|
|Kitasato University School of Medicine|
|Kanagawa, Japan, 228-8555|
|Kyoto Prefectural University of Medicine|
|Kyoto, Japan, 602-0841|
|Nagasaki University Hospital|
|Nagasaki, Japan, 852-8501|
|Okayama University Medical School|
|Okayama, Japan, 700-8558|
|Saitama Cancer Center|
|Saitama, Japan, 362-0806|
|Tokushima University Hospital|
|Tokushima, Japan, 770-8503|
|Nippon Medical School|
|Tokyo, Japan, 113-8603|
|University of Tokyo Hospital|
|Tokyo, Japan, 113-8655|
|Cancer Institute Hospital of Japanese Foundation for Cancer Research|
|Tokyo, Japan, 135-8550|
|National Hospital Organization - Tokyo Medical Center|
|Tokyo, Japan, 152-8902|
|Keio University School of Medicine|
|Tokyo, Japan, 160-8582|
|Tokyo Women's Medical University|
|Tokyo, Japan, 162-8666|
|Study Chair:||Hidetoshi Yamanaka, MD, PhD||Kurosawa Hospital|