Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer
NCT ID: NCT00534196
Last Updated: 2023-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6927 participants
OBSERVATIONAL
2005-07-31
2021-12-13
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Permanent iodine-125 (Brachytherapy)
Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.
Interventions
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Permanent iodine-125 (Brachytherapy)
Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.
Eligibility Criteria
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Inclusion Criteria
* Clinically and histologically confirmed localized prostate cancer
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* No prior or concurrent surgery
* No prior or concurrent radiotherapy
* Prior chemotherapy, hormonal therapy, and biologic therapy allowed
MALE
No
Sponsors
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Kurosawa Hospital
UNKNOWN
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
OTHER
Responsible Party
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Principal Investigators
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Shiro Saito, MD, PhD
Role: STUDY_CHAIR
National Hospital Organization Tokyo Medical Center
Locations
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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
Osaka University Graduate School of Medicine
Suita, Osaka, Japan
National Hospital Organization - Saitama National Hospital
Wako, Saitama, Japan
Shiga University of Medical Science
Ōtsu, Shiga, Japan
Shimane University Hospital
Izumo, Shimane, Japan
University of Fukui Hospital
Fukui, , Japan
Hamanomachi Hospital
Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Gifu University Graduate School of Medicine
Gifu, , Japan
Gunma Cancer Center
Gunma, , Japan
Kitasato University School of Medicine
Kanagawa, , Japan
Kyoto Prefectural University of Medicine
Kyoto, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Okayama University Medical School
Okayama, , Japan
Saitama Cancer Center
Saitama, , Japan
Tokushima University Hospital
Tokushima, , Japan
Nippon Medical School
Tokyo, , Japan
University of Tokyo Hospital
Tokyo, , Japan
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, , Japan
National Hospital Organization - Tokyo Medical Center
Tokyo, , Japan
Keio University School of Medicine
Tokyo, , Japan
Tokyo Women's Medical University
Tokyo, , Japan
Countries
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References
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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.
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.
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.
Other Identifiers
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TUSM-BRI-GU-04-01
Identifier Type: -
Identifier Source: secondary_id
CDR0000562726
Identifier Type: -
Identifier Source: org_study_id
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