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In local advanced prostate cancer patients with clinically positive metastatic regional lymph node, the optimal treatment is still unanswered. For these patients, radiotherapy combined with hormonal therapy or hormonal therapy alone are recommended. Recently, the reports from NCCB and SEER data showed that radiotherapy combined with hormonal therapy have better survivals than hormonal therapy alone.
This randomized phase III trial compare hormonal therapy alone with combined hormone with radiotherapy in clinically pelvic lymph node metastatic prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hormonal therapy alone | No Intervention | total androgen ablation or antiandrogen therapy alone for 2-3 years | |
| Hormonal therapy with radiotherapy | Active Comparator | total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity modulated radiotherapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of recurrence-free survival between two treatment groups | expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy | 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of toxicities between two treatment groups | Compare adverse events accroding to CTCAE V4.0 between hormonal therapy alone group and hormonal therapy combined with radiotherapy group | 5-year |
| Comparison of quality of lifl between two treatment groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Park, M.D.,Ph.D | Korean Radiation Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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Compare quality of life accroding to Expanded prostate cancer index composite_Korean between hormonal therapy alone group and hormonal therapy combined with radiotherapy group |
| 5-year |
| Comparison of overall survival between two treatment groups | Compare overall survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group | 5-year |
| Comparison of clinical failure free survival between two treatment groups | Compare clinical failure free survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group | 5-year |
| Comparison of cause-specific survival between two treatment groups | Compare cause-specific survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group | 5-year |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |