Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer

What Was Tested

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

Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.

It had 1 arm (groups): Combination Therapy: Enzalutamide, Leuprolide, Radiotherapy (experimental).

The registry classes the interventions as drug and radiation.

More on the Plan

To determine time to biochemical failure as determined by the American Society for Radiation Oncology (ASTRO) Phoenix definition of nadir + 2 ng/mL, local progression, regional progression, and distant metastases.

To determine time to clinical progression free survival III.

To assess changes in PSA nadir and PSA and testosterone levels.

To assess changes in hemoglobin A1c (HbA1c), fasting glucose, fasting insulin and fasting lipid and cholesterol levels.

Who Took Part

Enrollment: 11 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: Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at very high risk of recurrence as determined by 2 or more of the following combinations:. Gleason score 8-10. Zubrod Performance Status 0-2 within 60 days prior to enrollment. Complete blood count (CBC) with differential obtained within 30 days prior to registration on study, with adequate bone marrow function defined as follows:. Absolute neutrophil count (ANC) ≥1,800 cells/mm3.

The full record lists 19 inclusion and 23 exclusion criteria; among the exclusions: definite evidence of metastatic disease; prior radical prostatectomy or bilateral orchiectomy for any reason; prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields.

How the Study Was Run

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

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 2015-12-22 with completion listed for 2020-08-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Acute Treatment-related Toxicity (time frame: From start of treatment to 90 days after completion of radiotherapy, approximately 6 months total). Percentage of Participants With Late Treatment-related Toxicity (time frame: From 90 days after completion of radiotherapy until end of study, approximately 30 months total). Proportion of Patients Achieving a Prostate Specific Antigen-Complete Response (PSA-CR) (time frame: Up to 127 days).

It also tracked 15 secondary outcomes, for example Median Time to Biochemical Failure, Median Time to Local Failure, Number of Participants With Regional or Distant Metastases Over Time, Median Time to Clinical Progression, Overall Median Change in Hemoglobin A1c (HbA1c) Levels During Treatment and Overall Median Change in Fasting Glucose Levels During Treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 11 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.