Is the PROTEUS data enough to change your practice in the treatment of patients with high-risk localized or locally advanced prostate cancer?
Assuming FDA approval, would you incorporate perioperative ADT + apalutamide for patients undergoing RP for high-risk localized or locally advanced prostate cancer?
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The question asks if the results of PROTEUS would/should impact practice patterns...let us take a look:
- ADT is not recommended to be used with radical prostatectomy in prostate cancer by any guideline.
- Apalutamide or any ARPI are not recommended to be used with RP in prostate cancer in any guideline...
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PROTEUS was a phase III RCT initially designed to evaluate if RP/ADT/APA (12 mo peri-op) was better than RP/ADT/Placebo in patients with high-risk localized prostate cancer on the co-primary endpoints of (1) major pathologic response and (2) MFS as adjudicated by blinded independent review of conven...
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PROTEUS was and is an important study showing that we can do meaningful neoadjuvant studies of contemporary agents in advanced prostate cancer.
At this time, however, given the limitations of the data currently available, the trial should not be considered practice-changing. First, the control arm fr...
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I might consider surgery with perioperative ADT in highly selected patients who decline radiation therapy or present with severe lower urinary tract/obstructive symptoms from BPH.
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