A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

What Was Tested

The trial (phase 2) is built around Degarelix.

This study is being offered to patients who have hormone resistant prostate cancer (HRPC).

This means that their prostate cancer is no longer responding to standard hormonal therapy.

The purpose of this study is to determine whether Degarelix will be able to stop the PSA from rising in patients with hormone resistant prostate cancer.

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

The registry classes the interventions as drug.

More on the Plan

This is a phase II study of a GnRH antagonist drug, Degarelix, for use in hormone resistant prostate cancer patients who have had biochemical PSA progression despite the use of total androgen blockade therapy.

Patients will receive at least six monthly injections of Degarelix unless the patient shows radiographic or symptomatic disease progression, intolerable toxicity or decides to withdraw from the study.

Who Took Part

5 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: Prior trial of total androgen blockade. Radiologically confirmed non-metastatic disease within 90 days of registration based on negative chest radiographs, CT Scan Abdomen/Pelvis and Bone scan. ECOG ≤ 2. Age ≥ 18 years. PSA ≥ 2.0 ng/ml.

The full record lists 14 inclusion and 11 exclusion criteria; among the exclusions: prior treatment with chemotherapy, radiopharmaceuticals, estrogen, pc-spes, ketoconazole or other second line hormonal therapy (other than non-steroidal anti-androgens or androcur); known allergy to gnrh agonists or antagonists; previous treatment with degarelix.

How the Study Was Run

The set-up was single-group and open-label.

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

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

It started in 2011-05 with completion listed for 2011-10.

It ran at 3 sites in Canada (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: PSA Progression (time frame: Monthly for 6 months then every 3 months).

It also tracked 3 secondary outcomes, for example Time to Disease progression and The impact of monthly injections of Degarelix on Health Related Quality of Life Issues in patients with prostate cancer.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Degarelix in 5 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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