Androgen Deprivation Therapy Muscle Protein Metabolism and Blood Glucose

What Was Tested

In this not phased trial, researchers set out to test Goserelin.

Although the negative effects of ADT on muscle mass are well documented, the cellular effects of ADT on muscle tissue are still largely unknown, and studies investigating the mechanisms are highly warranted.

Furthermore, understanding the cellular mechanisms through which ADT negatively influences muscle mass and glucose metabolism is important so that appropriate measures can be taken to counteract muscle wasting and comorbidities during ADT.

It had two arms (groups): ADT group (experimental) and No-ADT group (no intervention).

Prostate cancer patients currently receiving androgen deprivation therapy (Zoladex).

Prostate cancer patients without any history of receiving any form of androgen deprivation therapy.

The registry classes the interventions as drug.

More on the Plan

Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex), which leads to castrate levels of testosterone, experience troublesome side effects during and after treatment.

Thus, the real LBM gain following strength training in PCa patients on ADT may be hampered compared to healthy elderly men, but data on this is limited in the literature.

The planned acute recovery study is a continuation of the physical exercise and prostate cancer (PEPC) trial, which was a randomized controlled trial investigating the effects of strength training on body composition, muscle strength, and muscle cellular outcomes during ADT.

Interestingly, insulin resistance has been noted as early as three months into the treatment.

Who Took Part

Enrollment: 23 actual participants took part.

It was open to men only aged from 18 years up to 75 years.

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

Examples of who could join: Histologically verified prostate cancer, and either currently on Zoladex or without any current or no past usage of any ADT. Between 18 and 75 years of age. Treating oncologist/ study medical doctor´s (KMR) approval for participation. Signed informed consent must be obtained and documented according to Good Clinical Practice (GCP), and national/local regulations.

The full record lists 5 inclusion and 25 exclusion criteria; among the exclusions: routine resistance training (\>1 weekly session, last six months); treated with warfarin, or if seponation of acetylsalicylic acid is not recommended; conditions where heavy resistance exercise is contraindicated:.

How the Study Was Run

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

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

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

It started in 2018-09-21 with completion listed for 2023-03-02.

It ran at 1 site in Norway.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Muscle protein synthesis rate (time frame: The muscle biopsy will be collected two hours after the last exercise session).

It also tracked 4 secondary outcomes, for example Muscle cell signalling, Plasma insulin levels, Plasma glucose levels and Ribosomal RNA.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Goserelin in 23 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 Goserelin compound page, all human trials.