SABR in high-risk prostate cancer: Outcomes from two prospective clinical trials with and without elective nodal irradiation.
Bibliographic record
Abstract
3 Background: There is limited data on SABR in high-risk prostate cancer (PCa) especially regarding the role of elective nodal irradiation (ENI). This study compares two prospective phase II trials using SABR in high-risk prostate cancer, with and without ENI. Methods: Both trials enrolled patients with high-risk PCa only. Trial1 (pHART8) patients received 40Gy/5 to the prostate and 30Gy/5 to the seminal vesicles. Trial2 (SATURN) patients received 40Gy/5 to the prostate and 25Gy/5 to the pelvis and seminal vesicles. CTCAE and RTOG toxicities were collected. Biochemical failure (BF) was defined as nadir+2 and 4-year PSA response rate (4yPSARR) was < 0.4 ng/ml. Results: 60 patients were included (pHART8, n=30; SATURN, n=30). Median follow-up was 5.6y and 4.0y. Median nPSA was 0.02ng/ml for both. Six patients had BF, all from pHART8; four were managed with ADT and two are being observed. The BF rate was 14.6% at 5y in pHART8 and 0% in SATURN. All six biochemical failures were associated with a PSA of ≥ 0.4 ng/ml at 4y. 63% of patients in pHART8 and 93% in SATURN had a 4yPSARR. BF probability at 5y was 0% for those achieving a 4yPSARR, and 35.1% if not (p = p < 0.0001). Two patients died in pHART8, one from metastatic disease. One patient in SATURN died from other causes. No other patients developed metastatic disease, and one patient in pHART8 had CRPC. OS at 5y was 93.2% and 96.7% (p=0.86). There was significantly worse late GI and sexual toxicity in pHART8, but no difference in late GU toxicity between the two trials. Conclusions: SABR in high-risk prostate cancer yields biochemical control rates that are comparable to other radiotherapy modalities. ENI using SABR is feasible and led to a significant improvement in biochemical control as well as in 4yPSARR which proved to be a predictor of biochemical control, without an increase in late GI or GU toxicity. Longer follow-up would provide a better assessment of biochemical control. Clinical trial information: NCT01505075 and NCT01953055.
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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 | 0.012 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.005 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".