Clinical trial NCT03241537: COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostate Neoplasm
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 61
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Comparison of recurrence-free survival between two treatment groups
timeFrame: 5-year
Secondary outcomes:
measure: Comparison of toxicities between two treatment groups
timeFrame: 5-year
measure: Comparison of quality of lifl between two treatment groups
timeFrame: 5-year
measure: Comparison of overall survival between two treatment groups
timeFrame: 5-year
measure: Comparison of clinical failure free survival between two treatment groups
timeFrame: 5-year
measure: Comparison of cause-specific survival between two treatment groups
timeFrame: 5-year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Korean Radiation Oncology Group
name: Won Park, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: