What do oncologists think of the EMBARK trial (XTANDI®)?
EMBARK — Non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence
FDA APPROVED · Nov 2023FDA-approved November 16, 2023, for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
Physician voices — verbatim
Full physician voice list (12)
Full conference coverage and trial data: KOL Pulse trial profile coming soon.
What do oncologists think of the ENZA-p trial (XTANDI®)?
ENZA-p — Metastatic castration-resistant prostate cancer — enzalutamide + 177Lu-PSMA-617 (investigational combination)
INVESTIGATIONAL COMBINATIONThe enzalutamide + 177Lu-PSMA-617 combination studied in ENZA-p is investigational and not FDA-approved. Enzalutamide monotherapy is separately FDA-approved for metastatic castration-resistant prostate cancer.
Physician voices — verbatim
Full physician voice list (13)
Full conference coverage and trial data: KOL Pulse trial profile coming soon.
What do oncologists think of the ENZAMET trial (XTANDI®)?
ENZAMET — Metastatic castration-sensitive (hormone-sensitive) prostate cancer — first-line, with testosterone suppression
FDA-APPROVED SETTING · mCSPC (Dec 2019)Enzalutamide is FDA-approved for metastatic castration-sensitive prostate cancer (approved December 16, 2019, based on the ARCHES trial). ENZAMET is an investigator-initiated (ANZUP) trial providing additional evidence in this FDA-approved setting.
Physician voices — verbatim
Full physician voice list (2)
Full conference coverage and trial data: KOL Pulse trial profile coming soon.
XTANDI® — FDA status
FDA APPROVEDXTANDI® (enzalutamide) is an androgen receptor inhibitor FDA-approved across multiple prostate-cancer settings — metastatic castration-resistant prostate cancer (initial approval 2012), non-metastatic castration-resistant prostate cancer (2018), metastatic castration-sensitive prostate cancer (2019), and non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence (2023). For the full, current list of FDA indications and prescribing information, see xtandi.com or FDA label (DailyMed). KOL Pulse indexes the physician conversation; the label is owned and maintained by the manufacturer.
XTANDI® sentiment — FAQ
EMBARK
What do oncologists think of the EMBARK trial (XTANDI®)?
Across 12 verified physician voices in KOL Pulse's index for EMBARK, 25% expressed positive sentiment, 25% were nuanced (praising the result while flagging a caveat), 33% were neutral, and 17% were critical. Positive voices highlight the metastasis-free-survival benefit of enzalutamide (with leuprolide, or as monotherapy) in high-risk biochemically recurrent, non-metastatic castration-sensitive prostate cancer, and the option to intensify earlier; nuanced and critical voices flag patient selection and over-treatment of biochemical-recurrence-only disease, the toxicity and quality-of-life trade-offs of earlier ARPI exposure, and the monotherapy-versus-combination question.
Where can I find the EMBARK trial data for XTANDI® (enzalutamide)?
EMBARK is registered as NCT02319837 and studied XTANDI® (enzalutamide) in Non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence. KOL Pulse's EMBARK trial profile is coming soon.
ENZA-p
What do oncologists think of the ENZA-p trial (XTANDI®)?
Across 13 verified physician voices in KOL Pulse's index for ENZA-p, 16% expressed positive sentiment, 15% were nuanced (praising the result while flagging a caveat), 69% were neutral, and 0% were critical. Positive voices highlight whether adding the PSMA-targeted radioligand 177Lu-PSMA-617 to enzalutamide improves outcomes in mCRPC, and the role of PSMA imaging as a prognostic/predictive biomarker; nuanced and critical voices flag the phase 2 size and endpoints, the added toxicity and logistics of radioligand therapy, and how the combination fits alongside established enzalutamide use.
Where can I find the ENZA-p trial data for XTANDI® (enzalutamide)?
ENZA-p is registered as NCT04419402 and studied XTANDI® (enzalutamide) in Metastatic castration-resistant prostate cancer — enzalutamide + 177Lu-PSMA-617 (investigational combination). KOL Pulse's ENZA-p trial profile is coming soon.
ENZAMET
What do oncologists think of the ENZAMET trial (XTANDI®)?
Across 2 verified physician voices in KOL Pulse's index for ENZAMET, 0% expressed positive sentiment, 0% were nuanced (praising the result while flagging a caveat), 100% were neutral, and 0% were critical. Positive voices highlight the overall-survival benefit of adding enzalutamide to standard first-line testosterone suppression in metastatic castration-sensitive prostate cancer; nuanced and critical voices flag toxicity and the interaction with early docetaxel, and how ENZAMET's academic design and results align with the ARCHES registration data.
Where can I find the ENZAMET trial data for XTANDI® (enzalutamide)?
ENZAMET is registered as NCT02446405 and studied XTANDI® (enzalutamide) in Metastatic castration-sensitive (hormone-sensitive) prostate cancer — first-line, with testosterone suppression. KOL Pulse's ENZAMET trial profile is coming soon.
Regulatory
Is XTANDI® (enzalutamide) FDA approved?
XTANDI® is FDA-approved. KOL Pulse organizes this page by clinical trial and links out to the manufacturer's brand site and the FDA label for the full, current list of FDA indications and prescribing information — the label is owned and updated by the manufacturer, so we point to it rather than reproducing it.