Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

September 20, 2007
September 27, 2016
July 2005
November 2016   (final data collection date for primary outcome measure)
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.
PSA relapse-free survival
Complete list of historical versions of study NCT00534196 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Prostate Cancer
Radiation: Permanent iodine-125 (Brachytherapy)
Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.
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.
Intervention: Radiation: Permanent iodine-125 (Brachytherapy)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6927
November 2016
November 2016   (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
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00534196
CDR0000562726, TUSM-BRI-GU-04-01
Yes
Not Provided
Not Provided
Translational Research Informatics Center, Kobe, Hyogo, Japan
Translational Research Informatics Center, Kobe, Hyogo, Japan
Kurosawa Hospital
Study Chair: Hidetoshi Yamanaka, MD, PhD Kurosawa Hospital
Translational Research Informatics Center, Kobe, Hyogo, Japan
September 2016

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