COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer

NCT03241537 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: SMC2015-11-139-002
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comparison of toxicities between two treatment groups

  5-year

• Comparison of quality of lifl between two treatment groups

  5-year

• Comparison of overall survival between two treatment groups

  5-year

• Comparison of clinical failure free survival between two treatment groups

  5-year

• Comparison of cause-specific survival between two treatment groups

  5-year

Study Arms (2)

Hormonal therapy alone

NO INTERVENTION

total androgen ablation or antiandrogen therapy alone for 2-3 years

Hormonal therapy with radiotherapy

ACTIVE COMPARATOR

total androgen ablation or antiandrogen therapy for 2-3 years combined with radiotherapy on whole pelvis

Radiation: Intensity modulated radiotherapy

Interventions

Intensity modulated radiotherapy RADIATION

Hormonal therapy with radiotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Won Park, M.D.,Ph.D

  Korean Radiation Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 7, 2017
• Study Start: January 15, 2016
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)