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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Neoplasm
• Intervention / Treatment: Radiation: Intensity modulated radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Hormonal therapy alone; total androgen ablation or antiandrogen therapy alone for 2-3 years
Active Comparator: Hormonal therapy with radiotherapy; total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis	Radiation: Intensity modulated radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5-year
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	5-year
Comparison of overall survival between two treatment groups	Compare overall survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group	5-year
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	5-year
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	5-year

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Won Park, M.D.,Ph.D, Korean Radiation Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2016
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2026

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: August 1, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SMC2015-11-139-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No