Testosterone recovery for relugolix versus leuprolide in men with advanced prostate cancer: Results from the phase 3 HERO study.
Bibliographic record
Abstract
104 Background: In the phase 3 HERO study, the oral GnRH receptor antagonist, relugolix, showed sustained testosterone suppression superior to that of leuprolide (96.7% vs 88.8%; difference: 7.9% [95% CI, 4.1 to 11.8; P < 0.001]). Herein, we provide an analysis of the testosterone recovery data in a subgroup of 184 men from the HERO study who were not indicated to continue androgen deprivation therapy. Methods: The phase 3 HERO study was designed to evaluate relugolix in men with advanced prostate cancer. Overall, 934 men were randomized 2:1 to receive relugolix 120 mg orally once daily after a single oral loading dose of relugolix 360 mg on Day 1 or leuprolide injections every 12 weeks for 48 weeks. Testosterone recovery was assessed in 184 patients who completed 48 weeks of treatment and who did not plan to start alternative androgen deprivation therapy within the following 12 weeks (or within 24 weeks following the last injection of leuprolide 3-month depot). During the 90-day recovery period, assessments included time to testosterone recovery (≥ 280 ng/dL, the lower limit of the normal range) using the Kaplan-Meier method, PSA concentrations in testosterone recovery phase, and adverse events during the recovery phase. All analyses were conducted in a modified intent to treat population. Results: Overall, 137 men in the relugolix group and 47 men in the leuprolide group were included in these analyses. Mean (standard deviation) testosterone levels for men entering the recovery assessment were 427±142 ng/dL and 404±127 ng/dL in the relugolix and leuprolide groups, respectively. The cumulative incidence rate of testosterone recovery to ≥280 ng/dL at 90 days after drug discontinuation was 53.9% in the relugolix group compared with 3.2% in the leuprolide group (nominal p = 0.0017). Overall, 74 of the 137 men in relugolix group recovered testosterone with a median time to recovery of 86.0 days (95% CI: 65.0, 92.0), versus 2 of the 47 men in leuprolide group with a median time to recovery of 112.0 days (95% CI: 112.0, not estimable). At the 90-day follow-up visit, the median PSA values were 0.39 ng/mL (range: 0 to 233.1) and 0.06 ng/mL (0 to 14.0) in the relugolix and leuprolide groups, respectively. Incidence of adverse events were generally similar in the treatment groups during the recovery phase, with 96% of men experiencing at least one adverse event and 15% of men experiencing a grade ≥3 adverse event in both treatment groups during the recovery phase. Conclusions: Relugolix, an oral nonpeptide GnRH receptor antagonist, had a faster and more complete recovery of testosterone to normal levels after treatment discontinuation versus leuprolide in a subgroup of men from the phase 3 HERO study. Clinical trial information: NCT03085095.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".