Full Transcript

First Look at PROTEUS Results: Dr. Monty Pal on ASCO26 Plenary Research

1:29271 summary words · ~1 min readEnglishBy ASCOcancerTranscribed May 31, 2026

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Summary

The phase III PROTEUS study demonstrates that adding apalutamide to androgen deprivation therapy (ADT) before and after radical prostatectomy for localized prostate cancer significantly improves pathological complete response and reduces the risk of distant metastasis or death.

This clinical trial challenges the long-standing paradigm of surgery-alone for localized high-risk prostate cancer, potentially shifting clinical practice toward neoadjuvant and adjuvant systemic therapies.

Section summaries

Trial Design & Background

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Provides the essential baseline context of how the PROTEUS trial compares to the traditional surgical paradigm.

Efficacy Data & Conclusion

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Delivers the core statistical outcomes regarding pathological complete response and metastasis-free survival.

Key points

Challenging the Surgery-Alone Paradigm in Localized Prostate Cancer — While androgen deprivation therapy (ADT) has historically been paired with radiotherapy, radical prostatectomy has traditionally stood alone as a surgical treatment. The PROTEUS study investigates shifting this standard by integrating systemic dual-agent therapy (apalutamide + ADT) around the time of surgery.
Significant Survival and Metastasis-Free Benefits — The addition of apalutamide to ADT resulted in a 20% reduction in the risk of distant metastasis or death and a 10-fold higher odds ratio of achieving a pathological complete response (pCR).

“The Proteus study evaluated whether or not we can use the combination of apalutamide with androgen deprivation therapy and compare that to placebo with androgen deprivation therapy both before and after radical prostatectomy with pelvic lymph node dissection.” — Dr. Monty Pal

“We saw an increase in the cure success of radical prostatectomy with a very substantial hazard ratio. We also saw that there was a 10-fold higher odds ratio of pathological complete response and a 20% reduction in the risk of distant metastasis or death.” — Dr. Monty Pal

AI-generated from the transcript. May contain errors.

0:14

Hello everyone. I'm thrilled to be

0:16

discussing with you the results of the

0:17

Proteus study today. Now, this is a

0:19

really exciting trial that really holds

0:22

the potential to change the paradigm for

0:24

how we treat localized prostate cancer.

0:27

Now, of course, for many years now, we

0:28

know that androgen deprivation therapy

0:31

can actually complement outcomes with

0:32

radiotherapy, but surgery alone has

0:34

really stood as a paradigm. The Proteus

0:37

study evaluated whether or not we can

0:38

use the combination of apalutamide with

0:41

androgen deprivation therapy and compare

0:43

that to placebo with androgen

0:45

deprivation therapy both before and

0:47

after radical prostatectomy with pelvic

0:49

lymph node dissection. Now, this was a

0:51

large trial. There were over 2,000

0:53

patients randomized. Ultimately, the

0:56

results, I think, were incredibly

0:57

impressive. We saw an increase in the

0:59

cure success of radical prostatectomy

1:02

with a very substantial hazard ratio. We

1:04

also saw that there was a 10-fold higher

1:06

odds ratio of pathological complete

1:08

response and a 20% reduction in the risk

1:11

of distant metastasis or death. All of

1:14

these, I think, strongly favor

1:16

consideration of apalutamide with ADT

1:18

ahead of surgery. Again, [snorts] you

1:20

know, I think this could reflect a major

1:22

paradigm shift in how we treat the

1:23

disease and many congratulations to the

1:25

authors for this outstanding work.

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