The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer

What Was Tested

The trial (not phased) is built around Degarelix.

It had two arms (groups): GnRH antagonist + FSH + testosterone (other) and GnRH antagonist + testosterone (other).

The registry classes the interventions as drug.

More on the Plan

Normally, prostate specific antigen (PSA), which is a marker for prostate disease and progression, is exclusively produced in response to testosterone.

The men are currently recruited and during 5 weeks undergoing: 1.

Testosterone (T) treatment of all (group A and B) w 4-5; 4.

End and follow up after 5 weeks.

Who Took Part

33 actual participants took part.

It was open to men only aged from 20 years up to 30 years.

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Everyone knew when Degarelix was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-09-16 with completion listed for 2019-12-20.

It ran at 1 site in Sweden.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: PSA-concentration (time frame: 5 weeks).

It also tracked 1 secondary outcome, for example FSH dependent proteins.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Degarelix in 33 people.

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

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.