Intermittent Treatment With Degarelix of Patients Suffering From Prostate Cancer

What Was Tested

This registered phase 3 trial tested Degarelix.

The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.

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

The registry classes the interventions as drug.

More on the Plan

The off-treatment period(s) started when prostate-specific antigen (PSA) ≤4 ng/mL and lasted up to 24 months based on PSA levels.

A visit was scheduled on a monthly basis during the induction treatment periods, and every two months during the off-treatment periods.

During the off-treatment periods, degarelix treatment was re-initiated when PSA \>4 ng/mL.

The maximum of degarelix IAD treatment cycles that a participant could receive was limited to three.

Who Took Part

Enrollment: 220 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: Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), and is in need of androgen deprivation treatment. Patients with Locally Advanced or Metastatic Prostate Cancer - Screening PSA level (measured at a central laboratory) must be \>4 ng/mL and ≤50 ng/mL. Is a male patient aged 18 years or older. Has an Eastern Cooperative Oncology Group score of ≤2. Has a life expectancy of at least 24 months.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy; has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema; has hypersensitivity towards any component of the investigational medicinal product.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Degarelix study: the participants and staff both knew the treatment.

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

It started in 2008-12 with completion listed for 2012-06.

It ran at 52 sites in France (20), Germany (10), Spain (7), Italy (6), Netherlands (5) and Belgium (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment (time frame: Up to 24 months after end of induction period).

It also tracked 7 secondary outcomes, for example Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD, Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD, Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment and Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Degarelix in 220 people.

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

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