EMBARK is a randomized Phase 3 study of enzalutamide plus leuprolide, enzalutamide monotherapy, and leuprolide alone in men with high-risk non-metastatic HSPC.
Pfizer announced: "the estimated primary completion date for the EMBARK clinical trial is mid-2020" pfizer.com/news/press-relea...
Did Pfizer publish any results of this trial yet? The trial includes an Enzalutamide monotherapy arm. I am very interested in these results.
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Jump to repliesWhat do they expect to be special with:
enzalutamide plus leuprolide?
This article reports: "To date, there is no approved therapy for patients who have PSA relapse after surgery and/or radiotherapy and are at high risk for metastatic disease. Androgen deprivation is the de facto standard and most commonly prescribed treatment in this setting. The EMBARK trial is designed to address this unmet need in high-risk, nonmetastatic, hormone-sensitive prostate cancer patients who recur after primary therapy." annalsofoncology.org/articl...
They hope the combination will cause metastases to occur later than with lupron alone. However, I am more interested in the monotherapy, testosterone will not be lowered then.
As of April 2020, EMBARK (Xtandi for high-risk recurrent non-mPC) has a primary completion date of September 15, 2023
clinicaltrials.gov/ct2/show...
ARCHES (Xtandi for mHSPC) was published several years ago:
ncbi.nlm.nih.gov/pmc/articl...
Pfizer amended the trial to be able to get primary endpoint results in mid 2020:
"The main purpose of the amendment is to revise the planned analyses of the primary and several secondary endpoints, which reduced the target sample size. Enrollment was completed earlier this year [2018]. With these changes, the estimated primary completion date for the EMBARK clinical trial is mid-2020. Previously, the expected primary completion date for EMBARK was March 2021."
pfizer.com/news/press-relea...
Therefore I asked whether anything was published yet or if there was an announcement that results will be presented at a conference soon.
Your info is out of date. In April of 2020, Pfizer amended the primary completion date to 2023.
You are correct, thank you. They just moved it from 2020 to 2023.
I asked my Uro about Xtandi as a monotherapy (I was on it with Firmagon injections), and he said without the injections the Xtandi would cause you to grow quite the rack....... he made it sound above and beyond man boobs, like maybe a C or D cup or something crazy....... Im not sure I believe him
I would take tamoxifen to avoid breast enlargement. Yes, otherwise the breasts will grow.
I think I heard there may be clotting issues with tamoxifin....... thats a big no-no for me
I think that is wise, with indications that COVID may be, in part, more problematic in people prone to clotting. I have just decided to discontinue it. The risk alone, without the added risk of COVID, was acceptable to me, being that asymptomatic PC is my only comorbidity.
I read recently that lung issues with many COVID patients were likely a matter of excessive thickening/clotting of blood. The virus seems to promote clotting. At least through this winter, I plan on doing things (whether by addition or subtraction) that might reduce my clotting risks.
Have to presume that they originally hoped to show increased PFS ( to CR) with the combo at 2 years but did not get it. So they extended it to 5 years in the hope of seeing better PFS and OS by that time vs ADT alone. Would be worth a boatload of money for Pfizer. Must assume no statistically significant difference at two years, otherwise they would report it.
Phase 3 ARCHES trial - Enzalutamide + ADT
Clinical trial
AMPLITUDE clinical trial
