A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Leuprolide.

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

The registry classes the interventions as drug and radiation.

Who Took Part

The registry lists 102 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: Pathologic biopsy proven adenocarcinoma of the prostate. At least one of the following criteria:. CN1 on conventional or PET imaging. Grade group 5. Grade group 4.

The full record lists 16 inclusion and 27 exclusion criteria; among the exclusions: clinical or radiographic evidence of distant metastatic disease by ct/bone scan; clinical or radiographic evidence of high probability of clinical t4 disease; prostate gland size \>80 cc measured by ultrasound or mri.

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 2020-11-06 with completion listed for 2027-05.

It ran at 6 sites in United States (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of patients experiencing biochemical failure.

It also tracked 5 secondary outcomes, for example Change in health related quality of life, Proportion of patients with undetectable post-treatment PSA, Proportion of patients with distant metastases and Overall survival.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Leuprolide in 102 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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