SAKK 08/15-promet: Multicenter, randomized phase II trial of salvage radiotherapy +/- metformin for patients with prostate cancer after prostatectomy.
Bibliographic record
Abstract
TPS157 Background: Salvage radiotherapy (SRT) is as a potentially curative treatment for prostate cancer (CaP) patients presenting biochemical relapse after radical prostatectomy (RP). Metformin is a well-known antidiabetic drug that has demonstrated anti-cancer and radio-sensitizing effects. We aim to study whether metformin combined with SRT will improve cancer control by prolonging time to progression (TTP). Methods: This is a multicenter, randomized (1:1) phase II trial of SRT (70Gy/35fr to the prostate bed) with or without metformin (850mg BID for 52 wks) (NCT02945813). Metformin 850mg q.d. is started 4 wks prior to SRT. Stratification variables include Gleason score, PSA at randomization, surgical margin status and ADT use (allowed if PSA > 0.5, R0, post-RP PSA-DT < 6 mos or pT3b). Major eligibility criteria include: histologically proven CaP adenocarcinoma pT2a-3b, pN0 or cN0, M0; RP > 12 wks before registration; PSA progression after RP defined as 2 consecutive rises with final PSA > 0.1 ng/mL or 3 consecutive rises; and PSA ≤ 2 ng/mL within 14 days prior to registration. A sample size of 170 patients (85 per arm) is planned based on the primary endpoint TTP. Using a type I error of 5% and a power of 80%, 62 events are needed to show superiority of the treatment arm under the alternative hypothesis that the hazard ratio (HR) is 0.65 (TTP at 18 mos of 80% in the control arm vs. 86.5% in the treatment arm). All efficacy endpoints will be analyzed based on the full analysis population. The treatment effect will be assessed using Cox regression with the treatment arm as independent variable and the stratification factors as strata. Correlative studies including prostate tissue, blood (metabolic parameters), saliva and feces (microbiota) will be performed. Conclusion: Centers in Switzerland, Germany and France (GETUG) will recruit patients for this study. If positive, these results could help elucidate the role of metformin in CaP and determine the design of a subsequent phase III trial. Clinical trial information: NCT02945813.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 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 | 0.003 |
| Insufficient payload (model declined to judge) | 0.014 | 0.002 |
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".