CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
ELIGARDdrug
Likely dose
ELIGARD 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02274779
NCT02274779Phase 2Completed

Multicentric Phase II Trial of Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (OLIGOPELVIS / GETUG P07)

Institut Cancerologie de l'Ouest·interventional·Posted Oct 24, 2014·Updated Feb 13, 2026

In Brief

A Phase 2 clinical trial evaluating ELIGARD for Prostate Cancer. Completed, enrolled 74 participants across 2 sites.

Detailed Summary

There is an increasing number of reports describing the existence of a proportion of prostate cancer patients who present with a reduced number of metastases (\<5 lesions) at relapse. This oligometastatic status has also been recognized in other tumor types such as melanoma, soft tissue sarcoma, liver, lung, and breast cancer, and has influenced the management of these malignancies in that a more radical treatment such as surgical resection has been employed. Positron Emission Tomography-Computed Tomography (PET-CT) studies with tracers such as choline or acetate are reliable tools to help with the diagnosis of oligometastatic disease after biochemical treatment failure in prostate cancer. An aggressive treatment combining androgen depriving therapy (ADT) and and high-dose irradiation to the oligometastatic lesions, as detected by PET-CT, may be proposed for these oligometastatic patients. Such a treatment strategy may hypothetically succeed to prolong the failure-free interval between two consecutive ADT courses, or even cure selected patients with limited metastatic burden. In this study the investigators plan to assess biochemical or clinical relapse-free survival at 2 years of prostate cancer with 1-5 oligometastases treated concomitantly with high-dose conformal Radiation Therapy and LH-RH agonists.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesFrance
CollaboratorsAstellas Pharma Inc

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 24, 2014
Enrollment StartAug 20, 2014
Primary CompletionJul 24, 2018
Study CompletionJul 22, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.7 years ago

Interventions

ELIGARDdrug

Hormone therapy is recommended Eligard 45 mg acting for 6 months. It will be ideally administered the day of start of radiation therapy or within 3 months before the first day of radiotherapy. Nevertheless, free prescription is left to investigators. When using other hormonal strategies (anti-androgen agonists, LHRH antagonists or LHRH), an administration for six months will be critical.