Multicentre phase II trial of combination neoadjuvant hormone therapy and weekly docetaxel prior to radical prostatectomy in high risk localized prostate cancer (CUOG-P01a)
Bibliographic record
Abstract
4635 Background: Docetaxel is active for hormone refractory prostate cancer (HRPC) and may have additive effects if combined with androgen ablation in hormone naïve disease. Potential beneficial or adverse effects of combination vs sequential chemo-hormonal regimens are poorly defined. The objective of this trial was to assess the tolerability and pathologic effects (including high-throughput transcriptional and immunohistochemical bioprofiling) of 6 months of combined androgen ablation + docetaxel in men with high risk localized prostate cancer prior to radical prostatectomy. Methods: In a Phase II multicentre, single arm, open-label study men with newly diagnosed previously untreated clinically localized high-risk disease received androgen ablation (buserelin acetate 6.3 mg q 8 weeks x 3, + anti-androgen for 4 weeks) + weekly docetaxel (35 mg/m2 iv weekly x 6 q 8 weeks for 3 cycles). Results: 72 men with a mean age of 55 years (range 45–74) and mean serum PSA of 17.8 μg/L (range 2.5–66) were enrolled at 6 sites across Canada. Baseline prognostic factors included 51% cT2 and 38% cT3; 32% Gleason 7, 32% Gleason 8, and 27% Gleason 9; PSA <10 in 44%, 10–20 μg/L in 25%, and >20 μg/L in 31%. Eight patients discontinued study therapy for > grade 3 toxicity (n=5), withdrawal of consent (n=1), or identification of metastatic disease (n=2). 64 patients completed protocol therapy and surgery. 38 (59%) were pathological T2N0, including 2 complete responders (P-0) and 10 with residual microfoci of cancer. 26 (41%) were pT3, including 7 with seminal vesicle invasion (pT3c), and 4 T3N1. Positive surgical margins were identified in 17 (27%), including 5 pT2 and 12 pT3 tumors. Conclusion: Combined androgen ablation + weekly docetaxel is reasonably well tolerated and results in significant pathologic responses and lower than expected positive surgical margins for this high-risk group. Tissue microarray construction and transcriptional profiling are underway to define treatment-induced changes in gene expression. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis; Novartis; OncoGenex Abbott; Avenits; Novartis Aventis
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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) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.004 |
| 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".