A randomized, double-blind, placebo-controlled trial of metformin in reducing progression among men on expectant management for low-risk prostate cancer: The MAST (Metformin Active Surveillance Trial) study.
Bibliographic record
Abstract
LBA5002 Background: Active Surveillance (AS) involves vigilant monitoring of selected prostate cancer (PCa) patients, with radical treatment initiation upon significant disease progression. AS eligibility varies, generally including low-risk PCa men. Metformin, a widely-used oral hypoglycemic agent, is known for its excellent tolerability and efficacy in diabetes management. Extensive preclinical data suggested that metformin may slow PCa progression. The purpose of this study is to examine the effect of metformin on the rates of progression among men with low-risk localized PCa on AS. Methods: A randomized double blind placebo controlled trial was carried out in 14 centres across Canada.Eligible patients had biopsy-proven, low-risk, localized PCa diagnosed within the past 6 months, with a Gleason score of <6 observed in ≤1/3 of the total cores, less than 50% positivity in any one core, a PSA level of ≤10 ng/ml, and a clinical stage between T1c-T2a. Additionally, they chose active surveillance as their primary treatment. Subjects that met eligibility criteria were randomly assigned (1:1) to receive metformin 850 mg BID or placebo for 3 years. All patients underwent repeat prostate biopsy at 18 and 36 months. The primary endpoint indicated was time to progression, defined as the earliest occurrence of primary PCa therapy (e.g., prostatectomy, radiation, hormonal therapy) or pathological progression (>1/3 of total cores involved, at least 50% of any one core involved, or Gleason pattern 4 or higher). Results: In our cohort of 407 patients, 204 were administered metformin, and 203 received a placebo. The median age of the overall cohort was 63 years. Out of the total 407 patients, 141 experienced disease progression. There was no statistically significant difference in progression-free survival (PFS) observed between patients treated with metformin and those receiving placebo (p=0.63). Conclusions: Despite tantalizing preclinical and epidemiological data, metformin consumption does not alter rates of progression among men with low risk PCa on AS. Clinical trial information: NCT01864096 .
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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 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 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".