Phase I/II study of stereotactic ablative radiotherapy including regional lymph node irradiation for patients with high-risk prostate cancer (SATURN): Early results.
Bibliographic record
Abstract
264 Background: Dose escalation using five-fraction stereotactic ablative radiotherapy (SABR) is gaining popularity in the treatment of prostate cancer. This has not been extensively tested in the context of pelvic radiation for high-risk groups. The objectives of study are to report early toxicity and quality of life outcomes in patients following 5-fraction prostate and pelvic radiation. Methods: A phase I/II study was performed where high-risk prostate cancer patients (T3a-3b or Gleason score ≥ 8 or PSA > 20ng/ml) received 40Gy to prostate and 25Gy to pelvis and seminal vesicles in 5 weekly fractions, on a gantry-based platform. A 3mm planning target volume margin to the prostate and a 6mm margin to the lymph nodes was applied. Image guidance was performed using gold seed fiducials and cone beam computerized tomography. Androgen deprivation therapy (ADT) was used for 12-18 months. Common Terminology Criteria for Adverse Events version 3.0 was used to assess toxicities at 3- and 6-months. Quality of life data (QOL) was captured using EPIC questionnaire. A minimally clinically important change (MCIC) definition was triggered if the EPIC QOL score decreases > 0.5 SD, where SD is the standard deviation of baseline scores. Results: Thirty patients completed the planned treatment with a median follow up of 11.9 months (IQR 8.3, 13.0). The following toxicities were observed: grade 2 genitourinary (GU): 50% at 3 months and 34.5% at 6 months; grade 2 gastrointestinal (GI): 3.3% at 3months and 6.9% at 6 months. No ≥ grade 3 toxicities were observed. Mean (95% Confidence Interval) EPIC urinary QOL scores were 86.6 (81.9-91.3), 87.1(81.4-92.6) and 86.1(80.2-92.0) at baseline, 3 months and 6 months and the bowel scores were 94.1(91.3-97.0), 93.2(89.1-97.2) and 93.2(89.5-96.8), respectively. Proportion of patients experiencing MCIC at 3 months and 6 months were 27.8% and 31.8% for urinary domain, 23.5% and 28.6% for bowel domain; respectively. Conclusions: This gantry-based novel fractionation schedule incorporating pelvic radiation for high-risk prostate cancer in combination with ADT is feasible and well tolerated in the acute setting. Clinical trial information: NCT 01953055.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".