Earle Burgess: The best part of the oral prostate cancer session at ASCO24

Earle Burgess, Genitourinary Medical Oncologist, Atrium Health Levine Cancer Institute, shared a post on LinkedIn:

“What was the best part of the oral prostate cancer session at ASCO24 yesterday?

When an audience member asked why a control arm inferior to the standard of care was used in the randomized clinical trial being discussed.

Let me explain:

ARPI is equal to abiraterone, enzalutamide, darolutamide, apalutamide.

We know in metastatic castrate resistant prostate cancer (mCRPC) that use of an ARPI after a prior ARPI has failed basically doesn’t work.

However, we do have other life prolonging options in this setting that are routinely used in clinical practice.

New randomized phase 3 trials for patients with mCRPC who have failed a prior ARPI continue to be designed that compare fancy new drug regimen X to…..an ARPI.

This is effectively a placebo.

Using inferior control arms to compare new regimen X against an ineffective therapy increases the chance new regimen X wins….and harms patients.

There is a simple solution:  Don’t restrict the control arm to an ARPI in this setting.

Allow the treating physician to choose among all available life prolonging therapies.

Vinay Prasad talks about this important issue all the time.

If you’re unfamiliar with the concept, study his work.

Back to the audience member yesterday….bravo to that person!

I am glad to see that researchers from leading medical centers are increasingly addressing this issue out loud and in public.

Patients, KOLs, clinical trialists, advocacy groups, government agencies: demand better randomized clinical trial designs!”

Source: Earle Burgess/LinkedIn