Prostate Cancer
Conditions
Keywords
recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
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.
Interventions
RADIATIONPermanent iodine-125 (Brachytherapy)
Observational research was conducted by grouping Brachytherapy with/without PI (permanent iodine) seed implantation.
Sponsors
Kurosawa Hospital
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA relapse-free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 5 years | Dration from enrollment to the date of biochemical relapse or clinical relapse, overall survival (OS), cause-specific survival (CSS). |
| Quality of life | Baseline, Month 3, 12, 24 and 36 | 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 | Baseline, Month 3, 12, 24 and 36 | Evaluated by International Prostate Syndrom Score (IPSS) |
| Adverse events | 36 months | 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. |
Countries
Japan
Outcome results
None listed