Abiraterone +/- cabazitaxel in defining complete response in prostatectomy (ACDC-RP) trial.
Bibliographic record
Abstract
TPS5095 Background: Given recent advances in the management of de novo metastatic hormone-sensitive prostate cancer with both docetaxel and abiraterone, as well as evidence of significant activity of cabazitaxel in the post-abiraterone castrate-resistant setting, we hypothesized that the addition of cabazitaxel to neoadjuvant abiraterone will improve pathological complete response rates by overcoming mechanisms of resistance in localized high-risk prostate cancer. Aim: To determine the relative efficacy of the addition of cabazitaxel to abiraterone in the neoadjuvant treatment of prostate cancer to achieve a complete response. Methods: Open label, randomized, 2-arm multi-centre, phase 2 clinical trial. Primary endpoint: Pathological complete response rate (pCR). Secondary endpoints: surgical outcomes (positive margins, extracapsular extension, seminal vesicle or nodal involvement), pharmacodynamic markers in residual tumour (apoptosis, androgen receptor expression, localization, and signaling), biomarkers (intra-prostatic androgen levels), and safety. Design: Study participants will be randomized in a 1:1 ratio to receive either: Arm A: Abiraterone (1000 mg/day), prednisone (5 mg b.i.d.), leuprolide (22.5 mg s.c. every 3 months), and cabazitaxel (25 mg/m2 starting at week 2, with 6 mg pegfilgrastim 24 h following cabazitaxel) or Arm B: Abiraterone (1000 mg/day), prednisone (5 mg b.i.d.) and leuprolide (22.5 mg s.c. every 3 months). Assessments will take place biweekly for the first 12 weeks, then monthly until the prostatectomy (scheduled for 24 weeks following start of treatment). Target accrual is 88 participants within 36 months. Study is powered to detect a 15% difference with 85% power, assuming a one-sided type 1 error rate of 20%. A 6 patient safety run-in is included. As of Jan 2017, 1 site is open in Canada, with 4 additional Canadian sites and 1 site in Australia pending. To date, 4 participants are randomized and undergoing treatment. ACDC-RP is an investigator-initiated trial led by the Princess Margaret Urology Trials Group with funding from Ontario Institute for Cancer Research (OICR) and in-kind contributions from Janssen and Sanofi. Clinical trial information: NCT02543255.
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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 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".