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Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00534196
First received: September 20, 2007
Last updated: May 25, 2011
Last verified: July 2009
History of Changes
  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: iodine I 125

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS]

Resource links provided by NLM:

Drug Information available for: Iodine Iodide
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • PSA relapse-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • IPSS score [ Designated as safety issue: No ]

Estimated Enrollment: 7000
Study Start Date: July 2005
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
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
University of Tokyo Hospital
Tokyo, Japan, 113-8655
Keio University School of Medicine
Tokyo, Japan, 160-8582
National Hospital Organization - Tokyo Medical Center
Tokyo, Japan, 152-8902
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, Japan, 135-8550
Tokyo Women's Medical University
Tokyo, Japan, 162-8666
Nippon Medical School
Tokyo, Japan, 113-8603
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Investigators
Study Chair: Hidetoshi Yamanaka, MD, PhD Translational Research Informatics Center, Kobe, Hyogo, Japan
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

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: May 25, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013