Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Treatment | Closed | Any age | Other | TUSM-BRI-GU-04-01 BRI GU 04-01, NCT00534196 |
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.
Entry Criteria
Disease Characteristics:
- Clinically and histologically confirmed localized prostate cancer
Prior/Concurrent Therapy:
- No prior or concurrent surgery
- No prior or concurrent radiotherapy
- Prior chemotherapy, hormonal therapy, and biologic therapy allowed
Patient Characteristics:
- Not specified
Expected Enrollment
7000Outcomes
Primary Outcome(s)PSA relapse-free survival
Morbidity
Quality of life
IPSS score
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.
Trial Lead Organizations
Translational Research Informatics Center
 | | | |
| Hidetoshi Yamanaka, MD, PhD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Japanese Prostate Cancer Outcome Study by Permanent I-125 Seed Implantation [J-POPS] | |
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| Trial Start Date | 2005-07-01 | |
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| Trial Completion Date | 2015-12-31 (estimated) | |
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| Registered in ClinicalTrials.gov | NCT00534196 | |
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| Date Submitted to PDQ | 2007-08-20 | |
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| Information Last Verified | 2009-07-05 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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