A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide.

It had 1 arm (groups): ARN-509 Combined With Docetaxel (experimental).

* Apalutamide (ARN-509) will be taken orally at home daily * Docetaxel will be administered every 3 weeks intravenously * Prednisone will be taken orally twice daily * Leuprolide Acetate will be administered at the specification of the physician.

The registry classes the interventions as drug.

More on the Plan

This research study is a Phase II clinical trial.

The FDA has not approved the combination of the two drugs in any use.

In this research study, the investigators are evaluating the combination of two drugs, docetaxel with apalutamide.

Who Took Part

9 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 adenocarcinoma of the prostate. A castrate level of testosterone (\< 50ng/dL). Treatment with abiraterone acetate for CRPC in the past is required. Does not need to be the last treatment prior to enrollment. There is no limit to number of prior therapies. Metastatic disease by bone scan or other nodal or visceral lesions on CT or MRI.

The full record lists 23 inclusion and 21 exclusion criteria; among the exclusions: presence of untreated brain metastasis; medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry; persistent grade \> 1 (nci ctcae v4.0) aes due to investigational drugs that were administered more than 14 days before study enrollment.

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 2017-06-23 with completion listed for 2019-05-16.

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: To Evaluate Progression-free Survival on the Combination of Docetaxel Plus Apalutamide (time frame: Disease was evaluated radiologically at baseline and every 12 weeks on treatment; PFS follow up was up to 9.4 months).

It also tracked 5 secondary outcomes, for example Serum PSA Change From Baseline to 12 Weeks on Treatment and Overall Survival.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 9 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.