COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Open Label, Randomized Phase III Trial of Hormone Therapy Alone Versus COmbined HOrmone With Radiation Therapy in Clinical Pelvic Lymph Node Metastatic Prostate Cancer (COHORT Trial)

Conditions
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Prostate Neoplasm

Intervention / Treatment
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* Radiation: Intensity modulated radiotherapy


Participation Criteria
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Eligibility Criteria
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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: combined with distant metastasis (retroperitoneal lymph node, bone,...) previous history of antiandrogen therapy within 6 months of study enrollment previous history of definitive prostate cancer treatment such as prostatectomy previous history of pelvic radiotherapy previous history of other cancer treatment except for skin cancer and theroid cancer

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Hormonal therapy alone<br>total androgen ablation or antiandrogen therapy alone for 2-3 years | |
| Active Comparator: Hormonal therapy with radiotherapy<br>total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis | Radiation: Intensity modulated radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |