Prostate Neoplasm
Conditions
Brief summary
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.
Interventions
RADIATIONIntensity modulated radiotherapy
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* pathologically confirmed prostate cancer within 6 months for study enrollment * Clincally enlarged pelvic lymph node ((short axis 0.5 cm ≤) in imaging studies (CT, MRI, PET-CT) at diagnosis and partial response or complete remission of enlarged lymph nodes according to RECIST v1.1 after hormonal therapy for 2-3 months 3. age 20 ≤ 4. ECOG performance status 0-1 5. Optimal hematologic profiles within 6 months for study enrollment * Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 * Platelets ≥ 50,000 cells/mm3 * Hemoglobin ≥ 8.0 g/dl 6. Optimal kidney function within 6 months for study enrollment * Creatinine \< 2.0 ng/dL 7. Optimal liver functions within 6 months for study enrollment * total bilirubin \< 1.5 X maximum normal value * alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value
Exclusion criteria
1. combined with distant metastasis (retroperitoneal lymph node, bone,...) 2. previous history of antiandrogen therapy within 6 months of study enrollment 3. previous history of definitive prostate cancer treatment such as prostatectomy 4. previous history of pelvic radiotherapy 5. previous history of other cancer treatment except for skin cancer and theroid cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of recurrence-free survival between two treatment groups | 5-year | expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of toxicities between two treatment groups | 5-year | Compare adverse events accroding to CTCAE V4.0 between hormonal therapy alone group and hormonal therapy combined with radiotherapy group |
| Comparison of quality of lifl between two treatment groups | 5-year | Compare quality of life accroding to Expanded prostate cancer index composite\_Korean between hormonal therapy alone group and hormonal therapy combined with radiotherapy group |
| Comparison of overall survival between two treatment groups | 5-year | Compare overall survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group |
| Comparison of clinical failure free survival between two treatment groups | 5-year | Compare clinical failure free survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group |
| Comparison of cause-specific survival between two treatment groups | 5-year | Compare cause-specific survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group |
Countries
South Korea
Outcome results
None listed