EMBARK post hoc analysis of sexual activity (SA) patient-reported outcomes (PROs) in patients (pts) who were sexually active or interested in sex at baseline (BL).
Bibliographic record
Abstract
5084 Background: In EMBARK (NCT02319837), enzalutamide (ENZ) + leuprolide (L) or ENZ (ENZ mono) delayed metastasis-free survival vs placebo (P) + L while maintaining high quality of life (QoL) in high-risk biochemically recurrent nonmetastatic hormone-sensitive prostate cancer. SA (a composite score from European Organization for Research and Treatment [Tx] of Cancer QoL Questionnaire-Prostate 25 [QLQ-PR25]) was better preserved with ENZ mono vs P + L with no difference between ENZ + L vs P + L. To better understand effect on SA in relevant subgroups, we examined SA in pts who were sexually active or interested in sex at BL. Methods: QoL was assessed (BL, every 12 weeks) until metastasis/death. Cox regression was used to examine time to confirmed deterioration (TTCD) (confirmed at next visit) defined by one category change for sexual interest, activity, satisfaction, erectile function, and feeling like a man using QLQ-PR25 and FACT-P items (Table).Intent-to-treat analysis was applied. Results: Among pts interested in sex (n=694) or sexually active (n=437) at BL, TTCD in QLQ-PR25 SA domain, items 50 (interest), 51 (activity), GS7 (satisfaction), and BL5 (erectile function) were significantly delayed with ENZ mono vs P + L. In contrast, TTCD in BL5 (erectile function) was shorter with ENZ + L vs. P + L (Table). Conclusions: Among pts who were interested in sex or sexually active at BL, ENZ mono better preserved SA vs P + L in terms of SA domain, interest, activity, satisfaction, and maintaining erection. Adding ENZ to L had no impact on interest, activity, or satisfaction but may adversely affect erectile function, though differences in the median TTCD were clinically non-significant (0.06 months [1.8 days] and 0.09 months [2.7 days] in pts interested in sex and sexually active at BL, respectively). Clinical trial information: NCT02319837 . [Table: see text]
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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 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.009 | 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".