COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer

Prostate Neoplasm Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03241537
• Other study ID #: SMC2015-11-139-002
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 15, 2016
• Est. completion date: December 14, 2026

Study information

• Verified date: November 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: December 14, 2026
• Est. primary completion date: December 14, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Radiation:
• Intensity modulated radiotherapy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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