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Bending the Curve Trial by Trial
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HERO

Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer

Phase 3N = 930NCT03085095

Population
Men with advanced prostate cancer (930 patients received treatment)
Design
Phase 3 trial, 2:1 randomization to relugolix 120 mg orally once daily or leuprolide injections every 3 months for 48 weeks. Primary end point sustained testosterone suppression to castrate levels (below 50 ng per deciliter) through 48 weeks; non-inferiority and then superiority were tested.
Primary endpoint
Sustained castration rate
Arms
  • Leuprolide (control, n = 308): Leuprolide injections every 3 months
  • Relugolix (experimental, n = 622): Relugolix 120 mg orally once daily
People
Shore ND, HERO
Δ Sustained castration rate+7.9 points
Show the numbers
Results reported for HERO
EndpointAnalysisRelugolixLeuprolideEffect
Sustained castration ratePatients who received treatment (622 relugolix, 308 leuprolide)primaryShore 202096.7% (94.9–97.9%)88.8% (84.6–91.8%)P<0.001Proportion maintaining testosterone below 50 ng per deciliter through 48 weeks. The difference of 7.9 percentage points (95% CI 4.1 to 11.8) showed non-inferiority and superiority; P is for superiority.
Results reported for HERO
EndpointAnalysisRelugolixLeuprolideEffect
Sustained castration ratePatients who received treatment (622 relugolix, 308 leuprolide)primaryShore 202096.7% (94.9–97.9%)88.8% (84.6–91.8%)P<0.001Proportion maintaining testosterone below 50 ng per deciliter through 48 weeks. The difference of 7.9 percentage points (95% CI 4.1 to 11.8) showed non-inferiority and superiority; P is for superiority.
Primary publication: Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, et al. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med. 2020;382(23):2187-2196. PubMedDOI

Appears in

Sources

  1. Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, et al. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med. 2020;382(23):2187-2196.

    PubMedDOI