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Study of Brachytherapy With Iodine I-125 in Patients With Localized Prostate Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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No phase specified
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Treatment
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Active
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Any age
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Other
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TUSM-BRI-GU-04-01
BRI GU 04-01, NCT00534196
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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.
Entry Criteria Disease Characteristics:
- Clinically and histologically confirmed localized prostate cancer
Prior/Concurrent Therapy:
- No prior or concurrent surgery
- No prior or concurrent radiotherapy
- Prior chemotherapy, hormonal therapy, and biologic therapy allowed
Patient Characteristics:
Expected Enrollment 7000Outcomes Primary Outcome(s)PSA relapse-free survival
Secondary Outcome(s)Morbidity
Quality of life
IPSS score
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.
Trial Contact Information
Trial Lead Organizations Translational Research Informatics Center | | | | Hidetoshi Yamanaka, MD, PhD, Protocol chair | | | |
Trial Sites
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| Japan |
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| Aichi |
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Toyoake |
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| | | | | Fujita Health University |
| | | Ryoichi Shiroki, MD | |
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| Ehime |
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Matsuyama |
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| | | | Shikoku Cancer Center |
| | | Katsuyoshi Hashine, MD | |
| | Email:
khashine@shikoku-u.go.jp |
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Toon |
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| | | Ehime University Hospital |
| | | Tetsuhiro Ikeda, MD, PhD | |
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| Fukui |
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Fukui |
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| | | | University of Fukui Hospital |
| | | Osamu Yokoyama, MD, PhD | |
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| Fukuoka |
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Fukuoka |
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| | | | Kyushu University Hospital |
| | | Yasuhiro Tada, MD, PhD | |
| | Email:
tada@uro.med.kyushu-u.ac.jp |
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Fukuoka-shi |
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| | | Hamanomachi Hospital |
| | | Shuji Kotoh, MD | |
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| Gifu |
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Gifu-shi |
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| | | | Gifu University Graduate School of Medicine |
| | | Masahiro Nakano, MD, PhD | |
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| Gunma |
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Gunma |
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| | | | Gunma Cancer Center |
| | | Nobuaki Shimizu, MD, PhD | |
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Isesaki-shi |
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| | | Isesaki Municipal Hospital |
| | | Yutaka Takezawa, MD | |
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Maebashi |
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| | | Gunma University Graduate School of Medicine |
| | | Kazuhiro Suzuki, MD, PhD | |
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Takasaki-shi |
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| | | Kurosawa Hospital |
| | | Hidetoshi Yamanaka, MD, PhD | |
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| Hokkaido |
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Sapporo-shi |
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| | | | Sapporo Medical University |
| | | Masaru Takagi, MD | |
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| Hyogo |
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Kobe |
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| | | | Translational Research Informatics Center |
| | | Hidetoshi Yamanaka, MD, PhD | |
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| Ibaraki |
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Kasama |
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| | | | Ibaraki Prefectural Central Hospital |
| | | Mikinobu Ohtani, MD, PhD | |
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| Kagawa |
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Miki |
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| | | | Kagawa University Hospital |
| | | Yoshiyuki Kakehi, MD, PhD | |
| | Email:
kakehi@med.kagawa-u.ac.jp |
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| Kanagawa |
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Kanagawa |
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| | | | Kitasato University School of Medicine |
| | | Takefumi Satoh, MD, PhD | |
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| Kyoto |
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Kyoto |
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| | | | Kyoto Prefectural University of Medicine |
| | | Koji Okihara, MD, PhD | |
| | Email:
okihara@koto.kpu-m.ac.up |
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| Nagasaki |
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Nagasaki |
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| | | | Nagasaki University Hospital of Medicine and Dentistry |
| | | Hideki Sakai, MD | |
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| Okayama |
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Okayama |
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| | | | Okayama University Medical School |
| | | Yasutomo Nasu, MD, PhD | |
| | Email:
ynasu@md.okayama-u.ac.jp |
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| Osaka |
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Suita |
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| | | | Osaka University Graduate School of Medicine |
| | | Norio Nonomura, MD, PhD | |
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| Saitama |
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Saitama |
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| | | | Saitama Cancer Center |
| | | Yukio Kageyama, MD, PhD | |
| | Email:
ykageyama1@hotmail.com |
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Wako-shi |
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| | | National Hospital Organization - Saitama National Hospital |
| | | Tetsuo Momma, MD, PhD | |
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| Shiga |
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Otsu-shi |
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| | | | Shiga University of Medical Science |
| | | Keisei Okamoto, MD, PhD | |
| | Email:
keisei@belle.shiga-med.ac.jp |
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| Shimane |
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Izumo |
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| | | | Shimane University Hospital |
| | | Masahiro Sumura, MD | |
| | Email:
sumura@med.shimane-u.ac.jp |
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| Tokushima |
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Tokushima |
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| | | | Tokushima University Hospital |
| | | Tomoharu Fukumori, MD, PhD | |
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| Tokyo |
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Meguro-ku |
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| | | | National Tokyo Medical Center |
| | | Shiro Saito, MD | |
| | Email:
j-pops@bz01.plala.or.jp |
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Tokyo |
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| | | Cancer Institute Hospital of Japanese Foundation for Cancer Research |
| | | Junji Yonese, MD, PhD | |
| | | Keio University School of Medicine |
| | | Jun Nkashima, MD | |
| | | Nippon Medical School |
| | | Go Kimura, MD | |
| | | Tokyo Women's Medical University |
| | | Tetsuo Akimoto, MD, PhD | |
| | Email:
t-akimoto@rad.twmu.ac.jp |
| | | University of Tokyo Hospital |
| | | Kenshiro Shiraishi, MD, PhD | |
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| Registry Information | | | Official Title | | Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation
[J-POPS] | | | Trial Start Date | | 2005-07-01 | | | Trial Completion Date | | 2015-12-31 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00534196 | | | Date Submitted to PDQ | | 2007-08-20 | | | Information Last Verified | | 2008-03-30 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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