Study of Everolimus Added to Combined Hormonal and Radiation Therapy for High Risk Prostate Cancer

What Was Tested

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

Biomarkers are various traits which can be used to identify the progress of a disease or condition, which can help researchers determine the effect the study treatment has on the tumor.

Biomarkers can also help determine areas for further research.

It had 1 arm (groups): Everolimus with combined hormonal and radiation therapy (experimental).

The registry classes the interventions as other.

More on the Plan

However, despite impressive biochemical control, local control remains a problem.

The FDA has allowed their combined use in this clinical trial.

Who Took Part

1 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: Age ≥ 18 years. Participants must be able to care for themselves. Adequate kidney function. Histologically confirmed diagnosis of adenocarcinoma of the prostate with biopsy within 90 days of enrollment. No distant metastases as evaluated by a bone scan and CT of the pelvis (within 90 days of enrollment).

The full record lists 9 inclusion and 28 exclusion criteria; among the exclusions: any previous therapeutic radiation therapy to the pelvis; known gastrointestinal dysfunction or an inability to take oral medications that would preclude taking an oral medication; prior treatment with any investigational drug within the preceding 4 weeks of registration.

How the Study Was Run

Design: 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 2012-10 with completion listed for 2014-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Patients With Adverse Events on Oral Everolimus in Combination With Hormonal Ablation and External Beam Radiation (time frame: 64 months after beginning everolimus).

It also tracked 1 secondary outcome, for example Difference in Serologic Everolimus and Prostate Biomarker Levels Before and After Treatment With Everolimus.

What This Means in Plain Language

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

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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