AUA
  • Program
  • Register
  • Meeting Coverage
  • Guidelines
  • Industry Highlights
  • Science & Technology Hall
Topics
  • Meeting Coverage
  • Guidelines
  • Industry Highlights
  • Science & Technology Hall
Resources
  • Program
  • Register
Twitter iconFacebook iconInstagram iconYouTube iconLinkedIn icon
Apr 30, 2023

Dr. Shore presents practice-changing data in prostate cancer

EMBARK points to potential new standard of care for high-risk BCR.


Neal D. Shore, MD
Neal D. Shore, MD

The three-arm EMBARK study of leuprolide acetate (LA) plus enzalutamide (combo) vs. enzalutamide monotherapy (enza) vs. LA + placebo in patients with biochemically recurrent prostate cancer (BCR) showed statistically significant and clinically significant improvement in metastasis-free survival (MFS), risk of prostate-specific antigen (PSA) progression and time to first use of a new neoplastic agent.

The trial is potentially practice-changing for the specialty of urology.

“Enzalutamide in combination with leuprolide, if approved in this setting, has the potential to become a new standard of care for patients with high-risk BCR,” said Neal D. Shore, MD, medical director of the Carolina Urologic Research Center/GenesisCare U.S.

Up to 50% of patients experience BCR characterized by rising PSA within 10 years following definitive therapy for prostate cancer, Dr. Shore said during the Plenary session on Saturday. Patients with high-risk BCR have an increased risk of mortality.

EMBARK was a randomized, phase 3 trial in patients at high-risk, defined as a PSA-doubling time of ≤9 months and PSA ≥2 ng/mL above nadir post-radiotherapy or ≥1 ng/mL after radical prostatectomy with or without radiotherapy. Patients were randomized to enza 160 mg/day + LA, placebo + LA or enza monotherapy. If the PSA at week 36 was <0.2 ng/mL, therapy was stopped at week 37 and restarted when PSA was ≥2 ng/mL. The primary endpoint was metastasis-free survival. Key secondary endpoints included MFS for enza mono vs. placebo + LA, time to PSA progression, time to antineoplastic therapy and overall survival (OS).

A total of 1,068 patients were randomized 1:1:1 and followed for a median of 60.7 months. Patients were a median of 69 years of age, 83% Caucasian, 7% Asian and 4.5% Black. A third had prior hormonal therapy and 76% had PSA ≤10.

MFS for enza + LA and enza mono were significantly better than placebo +LA, HR=0.43 (95% CI 0.30-0.61; p<0.0001) and HR=0.63 (95% CI 0.46–0.87; p=0.0049), respectively. There were statistically significant improvements in risk of PSA progression, enza + LA HR=0.07 (95% CI, 0.03–0.14), enza mono HR=0.33 (5% CI, 0.23–0.49; both p<0.0001) and time to first new antineoplastic therapy, enza + LA HR=0.36 (HR 0.36; 95% CI, 0.26–0.49) and enza mono HR=0.54 (95% CI, 0.41–0.71; both p<0.0001).

Median overall survival has not yet been seen, Dr. Shore reported. Interim OS trended to favor enza + LA HR=0.59 (95% CI, 0.38–0.90; p=0.0142) and enza mono HR=0.77 (95% CI, 0.51–1.15; p=0.1963) but did not reach statistical significance.

Nearly all patients reported adverse events, most commonly fatigue and hot flashes. There were no new safety signals seen in the trial and adverse events and the enza safety profile were consistent with previous clinical studies.

See The Journal of Urology® for more information on the EMBARK study.

Interesting Stories
Reshaping BPH Treatment with the iTind™ Procedure
Sponsored by Olympus
Reshaping BPH Treatment with the iTind™ Procedure
Pacific Edge Announces Key Activities at AUA2023
Sponsored by Pacific Edge Diagnostics
Pacific Edge Announces Key Activities at AUA2023
Don’t miss a thing with AUANews
Sponsored by AUA
Don’t miss a thing with AUANews
Check out the AUA’s brand new Gold Open Access journal, <i>JU Open Plus</i>
Sponsored by AUA
Check out the AUA’s brand new Gold Open Access journal, JU Open Plus
More Content
Getty Images 910070326
Meeting Coverage
Saddle up for AUA2024 in San Antonio
May 11, 2023
Getty Images 1400488393
Meeting Coverage
Healthy debates
May 11, 2023
Getty Images 1345835999
Meeting Coverage
Claim your CME
May 11, 2023
Screen Shot 2023 05 10 At 12 15 03 Pm
Meeting Coverage
Must-see TV
May 11, 2023
Screen Shot 2023 05 02 At 4 48 03 Pm
Meeting Coverage
Read all about it
May 11, 2023
Guide And Rec
Meeting Coverage
Medical guidelines and recommendations take center stage at AUA2023
May 05, 2023
Yeonsoo Sara Lee, BS, medical student
Meeting Coverage
AUA2023 through the eyes of an MD candidate
May 05, 2023
Screen Shot 2023 05 03 At 1 16 42 Pm
Meeting Coverage
AUA2023 On Demand
May 05, 2023
Peter R. Carroll, MD, MPH
Meeting Coverage
Accolades in urology
May 05, 2023
Screen Shot 2023 05 02 At 4 48 33 Pm
Meeting Coverage
Mark your calendars for AUA2024
May 05, 2023
Screen Shot 2023 05 02 At 4 48 03 Pm
Meeting Coverage
Read all about it
May 05, 2023
Isla P. Garraway, MD, PhD
Meeting Coverage
Genetic testing key to targeting prostate cancer
Apr 30, 2023
AUA
Twitter iconFacebook iconInstagram iconYouTube iconLinkedIn icon
© 2023 Ascend Media. All rights reserved.