Prostate CancerJ-POPSNCT00534196
Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer
An observational study of Prostate Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 31 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Permanent iodine-125 (Brachytherapy)
- Type of treatment
- Surgery or procedure
- How many people
- 6,927 participants
- Where
- 31 sitesJapan
- Study dates
- Jul 2005to 13 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Japan31 sites
University of Fukui Hospital
Fukui, 910-1193
Hamanomachi Hospital
Fukuoka, 810-8539
Kyushu University Hospital
Fukuoka, 812-8582
Gifu University Graduate School of Medicine
Gifu, 500-8705
Gunma Cancer Center
Gunma, 373-0828
Kagawa University Hospital
Hiragi, Kagawa-ken, 761-0793
Isesaki Municipal Hospital
Isesaki, Gunma, 872-0817
Shimane University Hospital
Izumo, Shimane, 693-8501
Kitasato University School of Medicine
Kanagawa, 228-8555
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, 309-1793
Translational Research Informatics Center
Kobe, Hyōgo, 650-0047
Kyoto Prefectural University of Medicine
Kyoto, 602-0841
Gunma University Graduate School of Medicine
Maebashi, Gunma, 371-8511
Shikoku Cancer Center
Matsuyama, Ehime, 790-0007
Nagasaki University Hospital
Nagasaki, 852-8501
Okayama University Medical School
Okayama, 700-8558
Shiga University of Medical Science
Ōtsu, Shiga, 520-21
Saitama Cancer Center
Saitama, 362-0806
Sapporo Medical University
Sapporo, Hokkaido, 060-8556
Osaka University Graduate School of Medicine
Suita, Osaka, 565-0871
Kurosawa Hospital
Takasaki, Gunma, 370-0852
Tokushima University Hospital
Tokushima, 770-8503
Nippon Medical School
Tokyo, 113-8603
University of Tokyo Hospital
Tokyo, 113-8655
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, 135-8550
National Hospital Organization - Tokyo Medical Center
Tokyo, 152-8902
Keio University School of Medicine
Tokyo, 160-8582
Tokyo Women's Medical University
Tokyo, 162-8666
Ehime University Hospital
Tōon, Ehime, 791-0295
Fujita Health University
Toyoake, Aichi-ken, 470-11
National Hospital Organization - Saitama National Hospital
Wako, Saitama, 351-0102
About this study
Official title: Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS]
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Permanent iodine-125 (Brachytherapy)
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permanent iodine-125 (Brachytherapy)Radiation
Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Permanent iodine-125 (Brachytherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (4)
Progression free survival (PFS)
Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS).
Measured: 5 years
Quality of life
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.
Measured: Baseline, Month 3, 12, 24 and 36
IPSS score
Evaluated by International Prostate Syndrom Score (IPSS)
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startJul 2005
- Primary completion30 Nov 2016
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Kurosawa Hospital
- Responsible party
- Sponsor
- Investigators
- Shiro Saito, MD, PhD, Study chair, National Hospital Organization Tokyo Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534196
- Sponsor's protocol ID
- CDR0000562726
- Other IDs
- TUSM-BRI-GU-04-01
- Acronym
- J-POPS
- Status last verified
- May 2022
- First submitted
- 20 Sep 2007
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29934842Nakano 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.
PubMed 26577301Saito 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.
PubMed 24840041
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS]
- ClinicalTrials.gov ID
- NCT00534196
- Acronym / sponsor ID
- J-POPS / CDR0000562726
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,927 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Kurosawa Hospital
- Study start
- Jul 2005
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group under operation of brachytherapy | – | Radiation: Permanent iodine-125 (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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permanent iodine-125 (Brachytherapy)Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation. | Radiation | Group under operation of brachytherapy |
Primary outcome
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.
4 secondary outcomes
Progression free survival (PFS)
Time frame: 5 years
Quality of life
Time frame: Baseline, Month 3, 12, 24 and 36
IPSS score
Time frame: Baseline, Month 3, 12, 24 and 36
Adverse events
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Derived from this study: PubMed 29934842Ito 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.
- Derived from this study: PubMed 26577301Nakano 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.
- Derived from this study: PubMed 24840041Saito 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiro Saito, MD, PhD study chair
National Hospital Organization Tokyo Medical Center
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 31 sites in Japan.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA relapse-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00534196, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.