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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS]

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Permanent iodine-125 (Brachytherapy)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group under operation of brachytherapy<br>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)<br>* Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA relapse-free survival | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS). | 5 years | 
| Quality of life | 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. | Baseline, Month 3, 12, 24 and 36 | 
| IPSS score | Evaluated by International Prostate Syndrom Score (IPSS) | Baseline, Month 3, 12, 24 and 36 | 
| Adverse events | 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. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer