Immediate Versus Deferred Androgen Deprivation Therapy,Goserelin for Recurrent Prostate Cancer After Radical Radiotherapy

What Was Tested

The trial (phase 3) is built around Goserelin.

First analysis is planned for 7 years after study recruitment is completed.

It had two arms (groups): Immediate ADT (other) and Deferred ADT (other).

The registry classes the interventions as drug.

More on the Plan

Recurrent prostate cancer after radical radiation therapy is a common problem with often a long interval from biochemical failure to the time of symptomatic relapse.

Androgen deprivation therapy (ADT) is the most commonly used intervention following radiation failure and currently is often started immediately after the recognition of biochemical failure in the absence of symptoms.

The general objective of the ELAAT trial is to determine the optimal timing of ADT in men with recurrent prostate cancer after radical radiotherapy.

Consenting patients who have undergone prior radical radiotherapy for prostate cancer and are now experiencing a recurrence will be screened for eligibility.

Who Took Part

Enrollment: 79 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: Males over 18 years of age with histological confirmation of adenocarcinoma of the prostate.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: patients who are within 4 years of their brachytherapy implantation date; patients with medical conditions in which goserelin or bicalutamide is contraindicated in the opinion of the supervising oncologist or urologist; patients with another active malignancy or malignancy treatment within 5 years (basal or squamous cell skin cancers are not excluded from this trial).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Goserelin group and the comparison group ran side by side rather than switching.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-04 with completion listed for 2015-12.

It ran at 11 sites in Canada (11).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to androgen independent disease (AID). AID is defined as the time from randomization to AID or last follow-up (time frame: Every 6 months).

It also tracked 4 secondary outcomes, for example Time to complications of advanced malignancy (CAM) and number of CAMs experienced are secondary outcome measures, Quality of life, Cause Specific Survival and Overall survival.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 79 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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