Clinical trial NCT00534196: Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer
Official title: Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Kurosawa Hospital
First posted: 2007-09-24
Enrollment: 6927
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* 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

Primary outcomes:
measure: PSA relapse-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 5 years
measure: Quality of life
timeFrame: Baseline, Month 3, 12, 24 and 36
measure: IPSS score
timeFrame: Baseline, Month 3, 12, 24 and 36
measure: Adverse events
timeFrame: 36 months
Other outcomes:
Locations:
city: Toyoake
country: Japan
facility: Fujita Health University
state: Aichi
city: Matsuyama
country: Japan
facility: Shikoku Cancer Center
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Isesaki
country: Japan
facility: Isesaki Municipal Hospital
state: Gunma
city: Maebashi
country: Japan
facility: Gunma University Graduate School of Medicine
state: Gunma
city: Takasaki
country: Japan
facility: Kurosawa Hospital
state: Gunma
city: Sapporo
country: Japan
facility: Sapporo Medical University
state: Hokkaido
city: Kobe
country: Japan
facility: Translational Research Informatics Center
state: Hyogo
city: Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital
state: Ibaraki
city: Miki
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Suita
country: Japan
facility: Osaka University Graduate School of Medicine
state: Osaka
city: Wako
country: Japan
facility: National Hospital Organization - Saitama National Hospital
state: Saitama
city: Otsu
country: Japan
facility: Shiga University of Medical Science
state: Shiga
city: Izumo
country: Japan
facility: Shimane University Hospital
state: Shimane
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Fukuoka
country: Japan
facility: Hamanomachi Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Gifu
country: Japan
facility: Gifu University Graduate School of Medicine
city: Gunma
country: Japan
facility: Gunma Cancer Center
city: Kanagawa
country: Japan
facility: Kitasato University School of Medicine
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Okayama
country: Japan
facility: Okayama University Medical School
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School
city: Tokyo
country: Japan
facility: University of Tokyo Hospital
city: Tokyo
country: Japan
facility: Cancer Institute Hospital of Japanese Foundation for Cancer Research
city: Tokyo
country: Japan
facility: National Hospital Organization - Tokyo Medical Center
city: Tokyo
country: Japan
facility: Keio University School of Medicine
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
Study officials:
affiliation: National Hospital Organization Tokyo Medical Center
name: Shiro Saito, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.