Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer

What Was Tested

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

The main purpose of this study is to determine how tumors make androgens (male hormones), which makes these tumors more aggressive and resistant to hormonal therapy and how a short period of treatment with Apalutamide and leuprolide acetate prior to surgery can affect the production of these hormones in normal and malignant prostate tissue.

It had 1 arm (groups): Apalutamide + Leuprolide Acetate (experimental).

The registry classes the interventions as drug and procedure.

More on the Plan

Primary Objective: To evaluate the differential effect of neo-adjuvant leuprolide and Apalutamide on dihydrotestosterone (DHT) concentration in benign prostate tissue based on HSD3B1 genotype.

Secondary Objective(s): To evaluate the differential effect of neoadjuvant leuprolide and Apalutamide on other androgen (testosterone (T), dehydroepiandrosterone (DHEA), androstenediol, 5α-androstanedione (5α-dione), androstenedione (AD), androsterone and 5α-androstanediol) concentrations in benign and malignant prostate tissue based on HSD3B1 genotype.

Who Took Part

Enrollment: 54 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: Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Platelet count of ≥ 100k/mL independent of transfusion and/or growth factors within 3 months prior to randomization. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x ULN. Be capable of swallowing study agents whole as a tablet. Be willing/able to adhere to the prohibitions and restrictions specified in this protocol.

The full record lists 15 inclusion and 14 exclusion criteria; among the exclusions: current systemic steroid therapy (inhaled or topical steroids are also not allowed); active infection (eg, human immunodeficiency virus \[hiv\] or viral hepatitis); have a known history of pituitary or adrenal dysfunction.

How the Study Was Run

It was run as a single-group and open-label study.

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 2016-10-17 with completion listed for 2020-04-29.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Dihydrotestosterone (DHT) Concentration in Benign Prostate Tissue After a Combination Drug Treatment Based on Genotype Status (time frame: Up to 28 Days). Dihydrotestosterone (DHT) Concentration in Malignant Prostate Tissue After a Combination Drug Treatment Based on Genotype Status (time frame: Up to 28 Days).

It also tracked 7 secondary outcomes, for example Other Androgens Concentration in Benign Prostate Tissue After Neo-adjuvant Leuprolide and Apalutamide Based on Genotype Status.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 54 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.