COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer

Phase 3Active Not RecruitingNCT03241537

Samsung Medical Center61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Neoplasm

Interventions

Intensity modulated radiotherapyRADIATION

Eligibility

Sex: MALEMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 5-year

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 5-year

Data from ClinicalTrials.gov

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