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COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer

Samsung Medical Center logo

Samsung Medical Center

Status and phase

Active, not recruiting
Phase 3

Conditions

Prostate Neoplasm

Treatments

Radiation: Intensity modulated radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03241537
SMC2015-11-139-002

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

Male

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

61 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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