Every-other-day or once-a-week: Long-term efficacy outcomes of the multicenter randomised PATRIOT prostate SBRT trial.
Bibliographic record
Abstract
325 Background: We aim to report the long-term efficacy outcomes of the PATRIOT trial, a multicenter phase 2 randomised trial of every-other-day (EOD) versus once-a-week (QW) schedule for stereotactic body radiotherapy (SBRT) for prostate cancer (NCT01423474). Methods: Between January 2012 and November 2013, 152 men with low to intermediate risk prostate cancer were randomised to prostate SBRT 40Gy in 5 fractions, delivered EOD (n=75) or QW (n=77). The oncological outcomes evaluated were biochemical failure (BF) (based on Phoenix criteria), metastases free survival (MFS), prostate cancer specific survival (PCSS) and overall survival (OS). Time-to-event was estimated from the start date of SBRT to event of interest or last follow-up. The cumulative incidence of BF was estimated using the Nelson Aalen estimates, while MFS, PCSS and OS were estimated using the Kaplan Meier method. Results: The median follow-up for the cohort was 91 months (IQR: 61-116 months). Five men in the EOD arm and eight men in the QW arm developed BF. The 8-year cumulative incidence of BF were 5.5% (SE=0.03) in the EOD arm and 9.6% (SE=0.04) in the QW arm (P=0.3). None of the men in the EOD arm developed metastases, while three men in the QW arm did. The 8-year MFS were 100% in the EOD arm and 95.9% (95%CI=91.4-100%) in the QW arm (P=0.08). Thirteen men had died at last follow-up, of which two were prostate cancer specific death. The 8-year PCSS were 100% in the EOD arm and 97.2% (95%CI=93.5-100%) in the QW arm (P=0.3), while the 8-year OS were 96.0% (95%CI=91.7-100%) in the EOD arm and 85.4% (95%CI=76.4-95.5%) in the QW arm (P=0.3). Conclusions: There are no statistically significant differences in long-term oncological outcomes between EOD and QW for five-fraction prostate SBRT in the PATRIOT trial. However, the trial was powered for acute toxicity differences, and not MFS or OS. Either prostate SBRT schedule could be safely delivered depending on patients’ preference, or for logistic reasons. We plan to combine these data with the Swiss EOD vs QW randomised trial (NCT01764646) to improve the power to detect these important outcomes. Clinical trial information: NCT01423474 .
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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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 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) | 0.004 | 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".