Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Enrollment
- 6927
- Locations
- 31
- Primary Endpoint
- PSA relapse-free survival
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Adverse events(36 months)
- Progression free survival (PFS)(5 years)
- Quality of life(Baseline, Month 3, 12, 24 and 36)
- IPSS score(Baseline, Month 3, 12, 24 and 36)