Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide.

The standard of care for obese men starting Androgen deprivation therapy (ADT) is physician based dietary and exercise counseling.

Interventions to lessen the harmful effects of ADT are needed yet have been limited.

It had 1 arm (groups): Diet and exercise with BAE (experimental).

The registry classes the interventions as behavioral, device and drug.

Who Took Part

It was open to men only aged from 18 years with no upper age limit.

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

Examples of who could join: Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information (HIPAA authorization will be included in the informed consent). Males aged 18 years of age and above. Histological proof of adenocarcinoma of the prostate. Non-metastatic disease by computed tomography (CT), magnetic resonance imaging (MRI) or Nuclear medicine (NM) bone scan. Patients must have CT abdomen/pelvis with contrast prior to enrollment. Metastatic disease may be permitted if NOT starting on any concomitant therapy (ie chemotherapy, anti-androgens).

The full record lists 21 inclusion and 21 exclusion criteria; among the exclusions: prior hormonal therapy within 12 months of enrollment; planned concurrent cytotoxic chemotherapy or antiandrogens (ex. bicalutamide, abiraterone acetate, enzalutamide or any investigational agent); prior history of gastric, pancreatic, hepatic and/or splenic surgery.

How the Study Was Run

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

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

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

It started in 2020-11-16 with completion listed for 2023-08.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Number of participants who experience at least 5 percent weight loss (time frame: At 6 months).

It also tracked 4 secondary outcomes, for example Number of adverse events, Change in Blood Pressure, Change in Respiratory Rate and Change in Oxygen saturation.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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