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
TPS5077 Background: Androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) or surgical castration, either alone or combined with conventional non-steroidal anti-androgen (NSAA), 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 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 early use of enzalutamide, a more potent and effective androgen receptor blocker, will reduce residual AR signalling, and improve survival. The aim is to determine the effectiveness of ADT + enzalutamide versus ADT + conventional NSAA, as 1st line endocrine therapy for M1 PC. Methods: DESIGN Open label, randomised, stratified, 2-arm, intergroup, phase 3 trial including ANZ, Canada, UK and USA. ELIGIBILITY Metastatic PC starting 1stline ADT. STRATIFICATION Volume of disease, anti-resorptive therapy, comorbidities, early docetaxel use, study site. ENDPOINTS Overall survival (primary), PSA progression free survival (PFS), clinical PFS, health related quality of life, adverse events, cost-effectiveness. SAMPLE SIZE 1100 participants recruited over 2 years + 3.5 years minimum f/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 LHRHA or surgical castration plus either enzalutamide 160mg daily orally, or conventional oral NSAA until disease progression or prohibitive toxicity. ASSESSMENTS Baseline, days 29 and 85 then 12 weekly until clinical progression; imaging prior to randomisation and on progression (PSA and clinical). Tertiary correlative objectives include identification of prognostic/predictive biomarkers from archival tumour tissue and fasting bloods collected at baseline, week 24 and progression (PSA and clinical). Email: enzamet@ctc.usyd.edu.au Website: http://www.anzup.org.au/ Clinical trial information: ACTRN12614000110684.
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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) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| 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 | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.011 | 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".