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| ID | Type | Description | Link |
|---|---|---|---|
| TUSM-BRI-GU-04-01 |
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| Name | Class |
|---|---|
| Kurosawa Hospital | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Permanent iodine-125 (Brachytherapy) | Radiation | Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS). | 5 years |
| Quality of life |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Patients in Japan who is histologically confirmed adenocarcinoma of the prostate and planning to undergo treatment with PI or combination of PI with other treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Shiro Saito, MD, PhD | National Hospital Organization Tokyo Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujita Health University | Toyoake | Aichi-ken | 470-11 | Japan | ||
| Shikoku Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29934842 | Derived | Ito K, Saito S, Yorozu A, Kojima S, Kikuchi T, Higashide S, Aoki M, Koga H, Satoh T, Ohashi T, Nakamura K, Katayama N, Tanaka N, Nakano M, Shigematsu N, Dokiya T, Fukushima M; J-POPS Investigators. Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS): first analysis on survival. Int J Clin Oncol. 2018 Dec;23(6):1148-1159. doi: 10.1007/s10147-018-1309-0. Epub 2018 Jun 22. | |
| 26577301 |
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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.
| Baseline, Month 3, 12, 24 and 36 |
| IPSS score | Evaluated by International Prostate Syndrom Score (IPSS) | 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. | 36 months |
| Matsuyama |
| Ehime |
| 790-0007 |
| Japan |
| Ehime University Hospital | Tōon | Ehime | 791-0295 | Japan |
| Isesaki Municipal Hospital | Isesaki | Gunma | 872-0817 | Japan |
| Gunma University Graduate School of Medicine | Maebashi | Gunma | 371-8511 | Japan |
| Kurosawa Hospital | Takasaki | Gunma | 370-0852 | Japan |
| Sapporo Medical University | Sapporo | Hokkaido | 060-8556 | Japan |
| Translational Research Informatics Center | Kobe | Hyōgo | 650-0047 | Japan |
| Ibaraki Prefectural Central Hospital | Kasama | Ibaraki | 309-1793 | Japan |
| Kagawa University Hospital | Hiragi | Kagawa-ken | 761-0793 | Japan |
| Osaka University Graduate School of Medicine | Suita | Osaka | 565-0871 | Japan |
| National Hospital Organization - Saitama National Hospital | Wako | Saitama | 351-0102 | Japan |
| Shiga University of Medical Science | Ōtsu | Shiga | 520-21 | Japan |
| Shimane University Hospital | Izumo | Shimane | 693-8501 | Japan |
| University of Fukui Hospital | Fukui | 910-1193 | Japan |
| Hamanomachi Hospital | Fukuoka | 810-8539 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Gifu University Graduate School of Medicine | Gifu | 500-8705 | Japan |
| Gunma Cancer Center | Gunma | 373-0828 | Japan |
| Kitasato University School of Medicine | Kanagawa | 228-8555 | Japan |
| Kyoto Prefectural University of Medicine | Kyoto | 602-0841 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| Okayama University Medical School | Okayama | 700-8558 | Japan |
| Saitama Cancer Center | Saitama | 362-0806 | Japan |
| Tokushima University Hospital | Tokushima | 770-8503 | Japan |
| Nippon Medical School | Tokyo | 113-8603 | Japan |
| University of Tokyo Hospital | Tokyo | 113-8655 | Japan |
| Cancer Institute Hospital of Japanese Foundation for Cancer Research | Tokyo | 135-8550 | Japan |
| National Hospital Organization - Tokyo Medical Center | Tokyo | 152-8902 | Japan |
| Keio University School of Medicine | Tokyo | 160-8582 | Japan |
| Tokyo Women's Medical University | Tokyo | 162-8666 | Japan |
| Derived |
| Nakano M, Yorozu A, Saito S, Sugawara A, Maruo S, Kojima S, Kikuchi T, Fukushima M, Dokiya T, Yamanaka H. Seed migration after transperineal interstitial prostate brachytherapy by using loose seeds: Japanese prostate cancer outcome study of permanent iodine-125 seed implantation (J-POPS) multi-institutional cohort study. Radiat Oncol. 2015 Nov 14;10:228. doi: 10.1186/s13014-015-0532-3. |
| 24840041 | Derived | Saito S, Ito K, Yorozu A, Aoki M, Koga H, Satoh T, Ohashi T, Shigematsu N, Maruo S, Kikuchi T, Kojima S, Dokiya T, Fukushima M, Yamanaka H. Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS). Int J Clin Oncol. 2015 Apr;20(2):375-85. doi: 10.1007/s10147-014-0704-4. Epub 2014 May 21. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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