The Prostate Cancer Clinical Trials Working Group (PCCTWG) consensus criteria for phase II clinical trials for castration-resistant prostate cancer
Bibliographic record
Abstract
5057 Background: The clinical manifestations of castration-resistant metastatic prostate cancer pose challenges to the design of phase 2 trials. In 1999, PSAWG issued a consensus report to standardize phase 2 design and endpoint definitions. A reassessment is reported. Methods: At 4 meetings, and using electronic communication, PCCTWG is seeking consensus on the design and analysis of phase 2 trials that can inform decisions about proceeding to phase 3. Results: PCCTWG recognizes that trial objectives, and details of design and analysis depend on the agent under study. PCCTWG recommends: (i) A standard disease assessment that includes prior treatment history, bone scan, and CT of the chest, abdomen and pelvis; (ii) Revision of eligibility criteria to lower PSA thresholds and serum testosterone levels; (iii) Emphasis on time-to-event endpoints including clinical, biochemical (e.g. PSA) or radiologic progression, recognizing that molecular targeted agents may delay progression without influencing initial response. (iv) Independent reporting of biochemical, radiographic, and clinical outcomes, avoiding grouped categorizations of complete or partial response, or stable disease. (v) Treating for a minimum of 12 weeks before assessing disease status, as the onset of PSA declines are often delayed, verifying that an agent does not influence release of PSA from cells. (vi) RECIST criteria are appropriate for changes in measurable disease, separating nodal and visceral sites. (vii) Changes in bone scan should be reported as “new lesions” or “no new lesions”, confirming findings of progression on a second scan. (viii) Pain and analgesic intake should be assessed using validated scales. (ix) Due to inherent variability, randomization to experimental and control groups is preferred, and innovative designs, e.g. expanding selected arms of randomized phase 2 trials to phase 3. Conclusions: PCCTWG recommends increasing emphasis on time to event endpoints as decision aids in proceeding from phase 2 to phase 3 trials. The recommendations will evolve as data are generated from phase 3 studies on the ability of intermediate endpoints to predict for clinical benefit. Support: MSKCC SPORE (CA 92629), Prostate Cancer Foundation. No significant financial relationships to disclose.
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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 | 0.200 | 0.166 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.014 |
| Bibliometrics | 0.008 | 0.010 |
| Science and technology studies | 0.005 | 0.005 |
| Scholarly communication | 0.010 | 0.005 |
| Open science | 0.016 | 0.006 |
| Research integrity | 0.016 | 0.023 |
| Insufficient payload (model declined to judge) | 0.011 | 0.013 |
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".