PATRIOT Trial: Randomized phase II study of prostate stereotactic body radiotherapy comparing 11 versus 29 days overall treatment time.
Bibliographic record
Abstract
6 Background: Stereotactic body radiotherapy (SBRT) for the treatment of prostate cancer is rapidly increasing. Reported regimens differ in time, dose, and fractionation. We report the results of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL) and toxicity. Methods: Men with cT1-2b, Gleason <=7, and PSA <= 20 ng/mL prostate cancer were randomly assigned to 40 Gy in 5 fractions delivered every other day (11 days) vs. once per week (29 days) using gantry-based SBRT. QOL was assessed using the Expanded Prostate Cancer Index Composite (EPIC) at baseline, weeks 2, 4, 6, 12, months 6 and 12, then annually. Toxicity was graded according to RTOG Criteria. The primary end point was the proportion of patients with a minimum clinically important change (MCIC) in bowel QOL at any time during the acute (<=12 week) period and was analyzed by Fisher’s exact test with a two-sided p < 0.05 considered significant. MCIC was defined as a decrease in EPIC score of >0.5 standard deviation of the baseline value. ClinicalTrials.gov NCT01423474. Results: 152 men from 3 centres were randomized with a median follow-up of 13.1 months. Baseline characteristics were similar in both arms except for the International Prostate Symptom Score with medians of 4 vs. 7 in the 11 and 29 day groups, respectively (p=0.02). There were significant differences between the 11 and 29 day groups in the proportion of patients with acute MCIC in bowel (90.0% vs. 69.6%, p<0.01) and urinary (95.7% vs. 74.6%, p<0.01) scores, respectively. No differences were found in acute sexual (p=0.38) or hormonal (p=0.48) QOL. Worst acute grade 1, 2, 3 toxicities were 64, 18, 0% vs. 41, 11, 0% (p<0.01) for GI and 38, 32, 1% vs. 30, 34, 3% (p=0.69) for GU in the 11 and 29 day groups, respectively. There were no late grade 3+ GI toxicities. Late grade 3 GU toxicity occurred in 1 vs. 0 patients in the 11 and 29 day arms (p=0.32). Conclusions: Prostate SBRT delivered over 29 days was associated with superior bowel and urinary QOL compared to 11 days in the first 3 months of treatment. There were few severe (grade 3+) toxicities in either group. Follow-up is continuing to compare long-term outcomes. Clinical trial information: NCT01423474.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.000 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.012 | 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".