A Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer

What Was Tested

The trial (phase 3) is built around Degarelix.

The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.

It had three arms (groups): Injection A (active comparator), Injection B (experimental) and Injection C (experimental).

Degarelix s.c. standard injections.

Degarelix s.c. optimised injections.

Degarelix i.m. injections.

The registry classes the interventions as drug.

Who Took Part

The registry lists 120 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: Aged ≥18 years with a diagnosis of adenocarcinoma of the prostate (Gleason graded, all stages) where endocrine treatment is indicated. Able to provide written Informed Consent and willing and able to comply with trial procedures. Body mass index (BMI) between 18.5-30 kg/m2. Has a life expectancy of at least one year.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: current hormonal management of prostate cancer; previous endocrine therapy for prostate cancer within 3 months prior to the screening visit; any medical injection therapy that might interfere with degarelix injections.

How the Study Was Run

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

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

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

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

It started in 2015-12 with completion listed for 2017-05.

It ran at 3 sites in Finland (1), France (1) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Difference in the average patient reported injection site pain score between patients receiving the optimised and standard s.c. injections, as well as between patients receiving the i.m. and standard s.c. injections (time frame: From baseline to month 6).

It also tracked 3 secondary outcomes, for example Difference in skin colour values between pre- and post-injection.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Degarelix in 120 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.