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COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer

Phase 3
Active, not recruiting
Conditions
Prostate Neoplasm
Interventions
Radiation: Intensity modulated radiotherapy
Registration Number
NCT03241537
Lead Sponsor
Samsung Medical Center
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 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Male
Target Recruitment
61
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Hormonal therapy with radiotherapyIntensity modulated radiotherapytotal androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis
Primary Outcome Measures
NameTimeMethod
Comparison of recurrence-free survival between two treatment groups5-year

expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy

Secondary Outcome Measures
NameTimeMethod
Comparison of quality of lifl between two treatment groups5-year

Compare quality of life accroding to Expanded prostate cancer index composite_Korean between hormonal therapy alone group and hormonal therapy combined with radiotherapy group

Comparison of toxicities between two treatment groups5-year

Compare adverse events accroding to CTCAE V4.0 between hormonal therapy alone group and hormonal therapy combined with radiotherapy group

Comparison of cause-specific survival between two treatment groups5-year

Compare cause-specific survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group

Comparison of overall survival between two treatment groups5-year

Compare overall survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group

Comparison of clinical failure free survival between two treatment groups5-year

Compare clinical failure free survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group

Trial Locations

Locations (1)

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

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