Back to resultsCOHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer
Primary Purpose
Prostate Neoplasm
Status
Active
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intensity modulated radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Neoplasm
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:
- 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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Hormonal therapy alone
Hormonal therapy with radiotherapy
Arm Description
total androgen ablation or antiandrogen therapy alone for 2-3 years
total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis
Outcomes
Primary Outcome Measures
Comparison of recurrence-free survival between two treatment groups
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
Comparison of toxicities between two treatment groups
Compare adverse events accroding to CTCAE V4.0 between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Comparison of quality of lifl between two treatment groups
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 overall survival between two treatment groups
Compare overall survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Comparison of clinical failure free survival between two treatment groups
Compare clinical failure free survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Comparison of cause-specific survival between two treatment groups
Compare cause-specific survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03241537
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 14, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hormonal therapy alone
Arm Type
No Intervention
Arm Description
total androgen ablation or antiandrogen therapy alone for 2-3 years
Arm Title
Hormonal therapy with radiotherapy
Arm Type
Active Comparator
Arm Description
total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis
Intervention Type
Radiation
Intervention Name(s)
Intensity modulated radiotherapy
Primary Outcome Measure Information:
Title
Comparison of recurrence-free survival between two treatment groups
Description
expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy
Time Frame
5-year
Secondary Outcome Measure Information:
Title
Comparison of toxicities between two treatment groups
Description
Compare adverse events accroding to CTCAE V4.0 between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Time Frame
5-year
Title
Comparison of quality of lifl between two treatment groups
Description
Compare quality of life accroding to Expanded prostate cancer index composite_Korean between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Time Frame
5-year
Title
Comparison of overall survival between two treatment groups
Description
Compare overall survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Time Frame
5-year
Title
Comparison of clinical failure free survival between two treatment groups
Description
Compare clinical failure free survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Time Frame
5-year
Title
Comparison of cause-specific survival between two treatment groups
Description
Compare cause-specific survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group
Time Frame
5-year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Park, M.D.,Ph.D
Organizational Affiliation
Korean Radiation Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer
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