Status:
ACTIVE_NOT_RECRUITING
COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Prostate Neoplasm
Eligibility:
MALE
20+ years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2026
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03241537
Start Date
January 15 2016
End Date
December 14 2026
Last Update
November 27 2023
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351