Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Degarelix.

It had two arms (groups): GnRH agonist + radiation therapy (RT) (active comparator) and GnRH antagonist + radiation therapy (RT) (experimental).

The registry classes the interventions as drug and radiation.

More on the Plan

The irradiation is the same as in the reference therapy arm.

The minimum duration of androgen deprivation with GnRH agonist or antagonist therapy is 18 months.

For each patient, the duration of therapy must be elected upfront by the treating physician among three possible options: 18, 24 or 36 months.

Who Took Part

The registry lists 885 planned participants were the target.

It was open to men only aged from 18 years up to 80 years.

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

Examples of who could join: Histologically confirmed diagnosis of prostate adenocarcinoma. PSA ≥ 10 ng/ml and two of the following 4 criteria:. PSA ≥ 20 ng/ml,. Gleason sum ≥ 8,. CN1 (regional LN with a short axis length \>10mm by CT scan or MRI) or pathologically confirmed lymph nodes (pN1),.

The full record lists 14 inclusion and 17 exclusion criteria; among the exclusions: history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema; hypersensitivity towards the investigational drug; the following biological parameters :ast, alt, total bilirubin, prothrombin time, serum albumin above upper level of normal range no severe hepatic impairment (child pugh c).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

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

It started in 2017-09-25 with completion listed for 2023-08-23.

It ran at 39 sites in Spain (11), France (10), Belgium (8), Germany (3), Switzerland (3) and Italy (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression free survival (time frame: through study completion, an average of 1 year).

It also tracked 6 secondary outcomes, for example Clinical progression-free survival, ♦ Proportion of patients switching from GnRH antagonists to GnRH agonists, ♦ Overall survival, Incidence of clinical cardiovascular events and ♦ Incidence of urinary tract infection.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Degarelix in 885 people.

With 885 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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