Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer (J-POPS)

June 22, 2023 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

6927

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukui, Japan, 910-1193
        • University of Fukui Hospital
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Fukuoka, Japan, 810-8539
        • Hamanomachi Hospital
      • Gifu, Japan, 500-8705
        • Gifu University Graduate school of Medicine
      • Gunma, Japan, 373-0828
        • Gunma Cancer Center
      • Kanagawa, Japan, 228-8555
        • Kitasato University School of Medicine
      • Kyoto, Japan, 602-0841
        • Kyoto Prefectural University of Medicine
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Medical School
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital
      • Tokyo, Japan, 113-8603
        • Nippon Medical School
      • Tokyo, Japan, 113-8655
        • University of Tokyo Hospital
      • Tokyo, Japan, 135-8550
        • Cancer Institute Hospital of Japanese Foundation for Cancer Research
      • Tokyo, Japan, 152-8902
        • National Hospital Organization - Tokyo Medical Center
      • Tokyo, Japan, 160-8582
        • Keio University School of Medicine
      • Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University
    • Aichi
      • Toyoake, Aichi, Japan, 470-11
        • Fujita Health University
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0007
        • Shikoku Cancer Center
      • Toon, Ehime, Japan, 791-0295
        • Ehime University Hospital
    • Gunma
      • Isesaki, Gunma, Japan, 872-0817
        • Isesaki Municipal Hospital
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Graduate School of Medicine
      • Takasaki, Gunma, Japan, 370-0852
        • Kurosawa Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8556
        • Sapporo Medical University
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0047
        • Translational Research Informatics Center
    • Ibaraki
      • Kasama, Ibaraki, Japan, 309-1793
        • Ibaraki Prefectural Central Hospital
    • Kagawa
      • Miki, Kagawa, Japan, 761-0793
        • Kagawa University Hospital
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Graduate School of Medicine
    • Saitama
      • Wako, Saitama, Japan, 351-0102
        • National Hospital Organization - Saitama National Hospital
    • Shiga
      • Otsu, Shiga, Japan, 520-21
        • Shiga University of Medical Science
    • Shimane
      • Izumo, Shimane, Japan, 693-8501
        • Shimane University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Radiation: Permanent iodine-125 (Brachytherapy)
Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 5 years
Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS).
5 years
Quality of life
Time Frame: Baseline, Month 3, 12, 24 and 36
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
Time Frame: Baseline, Month 3, 12, 24 and 36
Evaluated by International Prostate Syndrom Score (IPSS)
Baseline, Month 3, 12, 24 and 36
Adverse events
Time Frame: 36 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Kurosawa Hospital

Investigators

  • Study Chair: Shiro Saito, MD, PhD, National Hospital Organization Tokyo Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

December 13, 2021

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria

September 20, 2007

First Posted (Estimated)

September 24, 2007

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000562726
  • TUSM-BRI-GU-04-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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