PMID-38143206 – Relugolix Testosterone Recovery HERO Study
Tutrone R, Saad F, George DJ, Tombal B, Bailen JL, Cookson MS, Saltzstein DR, Hanson S, Brown B, Lu S, Fallick M, Shore ND. Testosterone Recovery for Relugolix Versus Leuprolide in Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. Eur Urol Oncol. 2024;7(4):906-913.
Quick Reference
| Property | Value |
|---|---|
| PMID | 38143206 |
| DOI | 10.1016/j.euo.2023.11.024 |
| Year | 2024 |
| Journal | European Urology Oncology |
| Study Type | RCT (Phase III, post-hoc analysis) |
| Evidence Level | II |
| Sample | 184 patients (137 relugolix, 47 leuprolide) who discontinued treatment |
| Peptide(s) Studied | Relugolix |
Key Findings
- Cumulative testosterone recovery to >280 ng/dL at 90 days: 54% relugolix vs 3.2% leuprolide (P<0.001)
- Median recovery time: 86 days with relugolix vs 112 days with leuprolide
- Recovery to >=80% of baseline testosterone: 40% relugolix vs 2.1% leuprolide
- Relugolix demonstrated faster and more complete testosterone recovery after treatment cessation
- Results support relugolix as preferred for intermittent androgen deprivation therapy strategies
Study Design
Post-hoc analysis of patients who discontinued treatment in the Phase III HERO trial. Testosterone levels were monitored at 90 days after drug cessation. Cumulative incidence of testosterone recovery was analyzed using competing risk methods.
Limitations
- Post-hoc analysis of a subset of trial participants
- Unequal group sizes (137 vs 47) due to randomization ratio
- 90-day follow-up may not capture full recovery trajectory
- Selection bias possible (reasons for discontinuation may differ between groups)
- Not designed to assess clinical outcomes related to testosterone recovery
Clinical Relevance
Rapid testosterone recovery is clinically important for minimizing the duration of ADT-related side effects (sexual dysfunction, bone loss, metabolic changes, fatigue) and is essential for intermittent ADT strategies. This analysis provides strong evidence that relugolix's oral GnRH antagonist mechanism enables substantially faster hormonal recovery compared to depot leuprolide, likely due to the absence of pituitary downregulation and the drug's short half-life.
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#research #RCT #peptide #sexual-health #evidence-level-II