Prostate Medication, Metabolism and Gut Microbiota

What Was Tested

The trial (phase 4) is built around Degarelix for hyperparathyroidism.

PROMED is a prospective, single center translational multiple cohort study to investigate the association of prostate medication and gut microbiota.

The main aim is to investigate how prostate hormonal therapy (5-ARI, ADT) affects gut microbiota composition.

It had two arms (groups): Prostatic hyperplasia (experimental) and Prostatic cancer (experimental).

The registry classes the interventions as drug.

More on the Plan

PCa is the most common male cancer in Finland and most western countries.

Interestingly, although the incidence of indolent (latent) PCa is very similar throughout the globe, there is a remarkable global age-adjusted incidence variation (up to 40-fold difference between highest and lowest incidences).

Who Took Part

The registry lists 100 planned participants were the target.

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: Provision of signed and dated informed consent form. Ability and stated willingness to comply with all study procedures and availability for the duration of the study.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: any history of a fecal transplantation; recent (within 3 months or still symptomatic) gastroenteritis; antibiotic treatment within 3 months (expect for antibiotic prophylaxis related to prostate biopsies).

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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 2022-12-01 with completion listed for 2024-10-31.

It ran at 2 sites in Finland (2).

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Gut microbiota signature before 5-ARI therapy (time frame: before starting prostate 5-ARI medication). Gut microbiota signature after 5-ARI therapy (time frame: 2 months after starting prostate 5-ARI medication). Gut microbiota signature before ADT (LHRH antagonists) (time frame: before starting prostate degarelix).

It also tracked 2 secondary outcomes, for example Metabolic characteristics in the gut and systemic circulation after use of prostate medication and Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Degarelix in 100 people with hyperparathyroidism.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Degarelix compound page, Hyperparathyroidism research.