A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer

What Was Tested

This registered phase 4 trial tested Degarelix.

The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.

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

The registry classes the interventions as drug.

Who Took Part

230 actual participants took part.

It was open to men only aged from 18 years up to 79 years.

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

Examples of who could join: Has given written informed consent before any study-related activity is performed. Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment. Age greater than or equal to 18 years and less than 80 years. Easten Cooperative Oncology Group score ≤ 2. PSA ≥ 2 ng/mL at screening.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: previous or concurrent hormonal management of prostate cancer; contraindication for prescription of firmagon®; considered as a candidate for curative therapy.

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 2016-05 with completion listed for 2020-05-15.

It ran at 19 sites in India (19).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Frequency of adverse events (time frame: Up to Day 364). Severity of adverse events (time frame: Up to Day 364).

It also tracked 4 secondary outcomes, for example Cumulative probability of no Prostate Specific Antigen (PSA) failure, Cumulative probability of Progression Free Survival (PFS), Change in International Prostate Symptom Score (IPSS) and Change in physician's satisfaction score.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Degarelix in 230 people.

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

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