NCT03241537

COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer

Active, enrolled Phase 3 Last updated 27 November 2023

What this trial tests

Phase 3 trial testing Intensity modulated radiotherapy in Prostate Neoplasm in 61 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 January 2016

Primary endpoint
14 December 2026

14 December 2026

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	15 January 2016
Primary completion	14 December 2026
Estimated completion	14 December 2026
Sites	1 location across South Korea

Drugs / interventions tested

• Intensity modulated radiotherapy

Conditions studied

• Prostate Neoplasm — all drugs for Prostate Neoplasm →

Sponsor

Samsung Medical Center

Who can join

20 and older, male only, with Prostate Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hypofractionated radiation therapy combined with androgen deprivation therapy for clinically node-positive prostate cancer.
   Lee TH, Pyo H, Yoo GS, Jeon SS, et al · · 2024 · PMID 38946076 · DOI 10.3857/roj.2024.00080
2. Androgen deprivation alone versus combined with pelvic radiation for adverse events and quality of life in clinically node-positive prostate cancer.
   Lee TH, Pyo H, Yoo GS, Kim JH, et al · · 2024 · PMID 38589463 · DOI 10.1038/s41598-024-54976-z