Clinical trial · Interventional
COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer
Open Label, Randomized Phase III Trial of Hormone Therapy Alone Versus COmbined HOrmone With Radiation Therapy in Clinical Pelvic Lymph Node Metastatic Prostate Cancer (COHORT Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity modulated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Hormonal therapy alone
- description
- total androgen ablation or antiandrogen therapy alone for 2-3 years
- type
- ACTIVE_COMPARATOR
- label
- Hormonal therapy with radiotherapy
- description
- total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis
- interventionNames
- Radiation: Intensity modulated radiotherapy
Primary outcomes (1)
- measure
- Comparison of recurrence-free survival between two treatment groups
- timeFrame
- 5-year
- description
- expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available