Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in South Korea / NCT03241537
Active, not recruiting Phase 3

COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer

NCT03241537 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Phase 3
Started
2016-01-15
Last updated
2023-11-27

Condition(s) studied

Prostate Neoplasm

Investigational drug(s) / intervention(s)

Intensity modulated radiotherapy

Study 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.

Eligibility

Sex
MALE
Min age
20 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea

More Samsung Medical Center trials in South Korea

IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI Recruiting
Genomic Profiling of Pancreatic Cystic Tumors Starting soon
Head and Neck Cancer Omics/Integrated Precision Medicine (HOPE) Recruiting
Korean Stroke Cohort for Functioning and Rehabilitation-II Active, not recruiting
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer Recruiting

Other trials for the same condition

Prospective Study of Ultrahypofractionated Proton Beam Therapy for Localized Prostate Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03241537 on ClinicalTrials.gov ↗ ← All trials in South Korea