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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kurosawa Hospital
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00534196
First received: September 20, 2007
Last updated: September 27, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention
Prostate Cancer
Radiation: Permanent iodine-125 (Brachytherapy)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS]

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • PSA relapse-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS).

  • Quality of life [ Time Frame: Baseline, Month 3, 12, 24 and 36 ] [ Designated as safety issue: No ]
    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.

  • IPSS score [ Time Frame: Baseline, Month 3, 12, 24 and 36 ] [ Designated as safety issue: No ]
    Evaluated by International Prostate Syndrom Score (IPSS)

  • Adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 6927
Study Start Date: July 2005
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Male
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534196

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00534196     History of Changes
Other Study ID Numbers: CDR0000562726  TUSM-BRI-GU-04-01 
Study First Received: September 20, 2007
Last Updated: September 27, 2016
Health Authority: Japan: Translational Research Informatics Center Ethical Committiee

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 06, 2016