Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide.

It had two arms (groups): ARM 1 (experimental) and ARM 2 (experimental).

The registry classes the interventions as drug.

More on the Plan

Participants will be randomized to one of two study arms.

Randomization means that the participant is put into a group by chance.

It is like flipping a coin.

Neither participant nor the research doctor will choose what group participants are randomized to.

Who Took Part

75 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: Male greater than or equal 18 years of age. Histologically confirmed adenocarcinoma of the prostate without histological variants (including overt neuroendocrine differentiation, small cell neuroendocrine carcinoma features, sarcomatoid features, pure ductal adenocarcinoma, squamous or transitional cell carcinoma). Must have tissue available from the pre-treatment diagnostic biopsy (tissue blocks if possible; if not possible, 10 unstained slides from each positive core sample for a total of 30 slides). Participants must have the following features:. Intermediate-risk disease defined as Gleason 4+3=7 disease OR.

The full record lists 19 inclusion and 23 exclusion criteria; among the exclusions: prior systemic treatment with an azole drug within four weeks of screening visit; hypogonadism or severe androgen deficiency as defined by screening serum testosterone \< 200 ng/dl; acute coronary syndrome within 6 months of screening visit;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

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 2014-10 with completion listed for 2018-01.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD) (time frame: after RP approximately 24 weeks from study entry).

It also tracked 4 secondary outcomes, for example Participants With Pathologic Complete Response (pCR), Positive Surgical Margin Status and Median Prostate Specific Antigen (PSA) Nadir.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 75 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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