COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer
NCT ID: NCT03241537
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
61 participants
INTERVENTIONAL
2016-01-15
2026-12-14
Brief Summary
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This randomized phase III trial compare hormonal therapy alone with combined hormone with radiotherapy in clinically pelvic lymph node metastatic prostate cancer.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hormonal therapy alone
total androgen ablation or antiandrogen therapy alone for 2-3 years
No interventions assigned to this group
Hormonal therapy with radiotherapy
total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis
Intensity modulated radiotherapy
Interventions
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Intensity modulated radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
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
20 Years
MALE
Yes
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Principal Investigators
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Won Park, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Korean Radiation Oncology Group
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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SMC2015-11-139-002
Identifier Type: -
Identifier Source: org_study_id