The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide.

The hypothesis is that inverting the traditional sequence of radiotherapy can delay the time to treatment - induced bowel toxicity.

It had two arms (groups): Standard Radiotherapy Sequence Arm (active comparator) and Experimental Radiotherapy Sequence Arm (experimental).

Standard sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) first, then prostate/prostate bed last.

Experimental sequence of radiotherapy = whole pelvic lymphatics, proximal seminal vesicles, prostate (or prostate bed) last, prostate/prostate bed first.

The registry classes the interventions as drug and radiation.

More on the Plan

Long - term androgen deprivation (LTAD) and radiotherapy results in modest 10 year overall and biochemical - free relapse rates in patients with "High risk" disease .

Literature review reveals that there is only one published study of concurrent Docetaxel chemotherapy and external beam radiation.

Docetaxel inhibits the action of Bcl-2, through the phosphorylation of serine residues on the Bcl-2 molecule, promoting apoptosis via the caspase cascade , a pathway of cell apoptosis also utilized by ionizing radiation.

A comparison of predictors of radiation and androgen therapy resistance, compared to the dominant targets of docetaxol also highlights why docetaxol may be an ideal agent.

Who Took Part

The registry lists 86 planned participants were the target.

It was open to men only.

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

Examples of who could join: A histological diagnosis of adenocarcinoma of the prostate. Life expectancy greater than 5 years. ECOG performance status \< 1. Signed, written informed consent prior to randomization. Any one, or more, of the following criteria:.

The full record lists 19 inclusion and 9 exclusion criteria; among the exclusions: previous pelvic radiotherapy; sensitivity to docetaxel chemotherapy; grade 2 or greater nci ctcae version 3.0 neuropathy.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2007-05 with completion listed for 2017-02.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example total amount of Docetaxel that can be delivered and quality of life in patients receiving concurrent, weekly Docetaxel chemotherapy, in concert with long - term androgen deprivation (LTAD).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 86 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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