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Active, Not Recruiting

NCT Number: NCT03241537

COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Neoplasm Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensity modulated radiotherapy

Radiation

Primary outcomes

  1. Comparison of recurrence-free survival between two treatment groups

    Time frame: 5-year

    expected 5-year recurrence-free survival were 40% in hormonal therapy alone group and more than 80% in hormonal therapy combined with radiotherapy

Secondary outcomes

  1. Comparison of toxicities between two treatment groups

    Time frame: 5-year

    Compare adverse events accroding to CTCAE V4.0 between hormonal therapy alone group and hormonal therapy combined with radiotherapy group

  2. Comparison of quality of lifl between two treatment groups

    Time frame: 5-year

    Compare quality of life accroding to Expanded prostate cancer index composite_Korean between hormonal therapy alone group and hormonal therapy combined with radiotherapy group

  3. Comparison of overall survival between two treatment groups

    Time frame: 5-year

    Compare overall survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group

  4. Comparison of clinical failure free survival between two treatment groups

    Time frame: 5-year

    Compare clinical failure free survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group

  5. Comparison of cause-specific survival between two treatment groups

    Time frame: 5-year

    Compare cause-specific survival between hormonal therapy alone group and hormonal therapy combined with radiotherapy group

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2017
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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