Randomised phase 3 trial of enzalutamide in first-line androgen deprivation therapy for metastatic prostate cancer: The ANZUP ENZAMET Trial (ANZUP 1304).
Bibliographic record
Abstract
TPS5090 Background: Androgen deprivation therapy (ADT) is widely used as initial treatment for hormone-naive, metastatic prostate cancer (PC). Meta-analysis of RCTs showed a 3% absolute improvement in 5 year survival with the addition of non-steroidal anti androgen (NSAA) to ADT. Residual, low level androgen receptor (AR) signalling or agonist activity from conventional NSAA may provide a stimulatory signal to hormone-sensitive PC cells. We hypothesize that the early use of enzalutamide, a more potent and effective AR blocker, will reduce residual AR signalling and improve survival. The aim is to determine whether ADT + enzalutamide improves overall survival (OS) compared to ADT + conventional NSAA in M1 castrate-naïve PC. Methods: DESIGN: open label, randomised, phase 3 trial including ANZ, Canada, UK, Ireland and USA. ELIGIBILITY: metastatic PC starting first line ADT. STRATIFICATION: volume of disease, anti-resorptive therapy, comorbidities, planned early docetaxel use, study site. ENDPOINTS: OS (primary), PSA and clinical progression free survival (PFS), health related quality of life, adverse events and cost-effectiveness. Tertiary correlative objectives: identification of prognostic/predictive biomarkers from archival tumour tissue and fasting bloods collected at baseline, week 24 and progression. 1100 target participants + 3.5 years minimum follow-up for 80% power to detect a 25% reduction in the hazard of death assuming an OS rate at 3 years of 65% in control group. TREATMENT: medical or surgical castration plus either enzalutamide 160mg daily orally, or conventional oral NSAA until disease progression or prohibitive toxicity. Early docetaxel at investigator discretion. ASSESSMENTS: baseline, days 29 and 85 then 12 weekly until clinical progression; imaging prior to randomisation and on progression (PSA and clinical). 70 sites open with total accrual of 444 participants on 19th January 2016. ENZAMET is an international investigator-initiated cooperative group trial led by ANZUP Cancer Trials Group with funding from Astellas. ANZCTR: ACTRN12614000110684 Clinical trial information: NCT02446405.
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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 | 0.002 | 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 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
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".