NCT03241537Active, not recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 27 Nov 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 27 Jul 2017
- Start date
- 15 Jan 2016
- Primary completion date
- 14 Dec 2026
- Lead sponsor
- Samsung Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT03241537
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 61
- From 15 Jan 2016 to the primary completion date, 14 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- previous history of other cancer treatment except for skin cancer and theroid cancer
Other
- combined with distant metastasis (retroperitoneal lymph node, bone,...)
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.