Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide.

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.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

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. 2.

This daily recalibration will be based at least on bone structures.

Who Took Part

The registry lists 74 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically proven adenocarcinoma of the prostate. Patients aged 18 years or more. Previous radical treatment to the prostate (radiotherapy or surgery). 1-5 pelvic lymph node metastases detected with 18FCH-PET. A relapse in the dressing prostatectomy is associated possible. Upper limit of lymph node metastases: aortic bifurcation.

The full record lists 11 inclusion and 14 exclusion criteria; among the exclusions: bone or visceral metastatic relapse associated; para-aortic nodal relapse (the upper limit is tolerated aortic bifurcation); more than 5 lymph node metastases.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Leuprolide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-08-20 with completion listed for 2018-07-24.

It ran at 2 sites in France (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Median Relapse-Free Survival Time (Biochemical or Clinical) (time frame: 2 years).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 74 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.