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: December 17, 2013
Last verified: July 2009

September 20, 2007
December 17, 2013
July 2005
December 2015   (final data collection date for primary outcome measure)
PSA relapse-free survival [ Designated as safety issue: No ]
PSA relapse-free survival
Complete list of historical versions of study NCT00534196 on ClinicalTrials.gov Archive Site
  • Morbidity [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • IPSS score [ Designated as safety issue: No ]
  • Morbidity
  • Quality of life
  • IPSS score
Not Provided
Not Provided
 
Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer
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.

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.

Interventional
Not Provided
Primary Purpose: Treatment
Prostate Cancer
Radiation: iodine I 125
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
7000
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00534196
CDR0000562726, TUSM-BRI-GU-04-01
Not Provided
Not Provided
Translational Research Informatics Center, Kobe, Hyogo, Japan
Not Provided
Study Chair: Hidetoshi Yamanaka, MD, PhD Translational Research Informatics Center, Kobe, Hyogo, Japan
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP