AASUR in High Risk Prostate Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide.

It had 1 arm (groups): one (experimental).

Eligible patients will receive a total of 6 months of leuprolide, abiraterone, and ARN-509 to begin three months prior to RT and continuing until approximately 3 months post-RT. Patients will be assessed every 4 weeks (±1 week) (a cycle = 28 days) throughout their treatment with the study drugs, and at least once during RT.

The registry classes the interventions as drug and radiation.

Who Took Part

Enrollment: 64 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: Histological or cytologic evidence of adenocarcinoma of the prostate confirmed at local institution. At least one of the following:. Two or more high risk features OR. Gleason score 8-10. PSA ≥20 ng/mL within two months prior to registration.

The full record lists 26 inclusion and 28 exclusion criteria; among the exclusions: radiographic evidence of metastatic disease; prior use of non-steroidal anti-androgens (e.g., bicalutamide, flutamide, nilutamide) within 1 month before registration; prior treatment with medications known to lower the seizure threshold within 4 weeks of registration (see section 5.5.2 apalutamide for a list of prohibited medications).

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Leuprolide study did not mask who received what.

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

It started in 2016-05-12 with completion listed for 2026-01-22.

It ran at 11 sites in United States (11).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Biochemical Failure (time frame: 36 months).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 64 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.