OCOG-RATIONAL: A phase II randomized trial of optimal recurrence-directed therapy (RDT) without or with androgen-deprivation therapy (ADT) in radio-recurrent oligo-metastatic castrate sensitive prostate cancer (romCSPC).
Bibliographic record
Abstract
TPS305 Background: This is a Canadian, multi-center study that investigates whether addition of ADT to RDT improves oncological outcomes in early romCSPC. The primary outcome is a 36-month composite Progression-free survival (cPFS). Secondary outcomes include metastasis-free survival, time to salvage therapy, time to castrate-resistant PC, OS, Quality of Life and toxicity. Methods: Population: Patients with biochemical recurrence after definitive or adjuvant/salvage radiotherapy for localized prostate cancer (PC) with oligo-metastatic disease (≤5 sites) without or with local recurrence. All patients will be staged with conventional imaging (CT/BS), mpMRI, PSMA-PET and biopsy of the prostate if in situ. Randomization: Patients are randomized 1:1 to RDT versus RDT+ADT for 12 months and stratified for, i) presence of local recurrence (Y/N), ii) volume of metastatic disease [0 (local recurrence alone) versus 1-3 versus 4-5 metastases]. iii) treatment centre, and iv) metastasis detected on conventional imaging (Y/N). Interventions: RDT options include Stereotactic Body Radiotherapy (SBRT), hypo-fractionated radiotherapy (HFRT), brachytherapy and surgical resection. Concurrent and adjuvant ADT involves four 3-month leuprolide acetate injections. Statistics: A clinically meaningful improvement for the use of ADT is defined as an improvement in the 30-month cPFS of ≥20% (from 50% to 70%). With an expected accrual period of 3 years, an additional 1 year of follow-up, a 1-sided log-rank test with α=0.05 would have over 80% power to distinguish between the two group with 73 patients in each arm. This number is inflated by 10% for stratification factors and patients lost-to-follow-up, for a total of 162 patients. Coordination: The study is coordinated by the Ontario Clinical Oncology Group (OCOG) and is expected to open in 10-12 institutions across Canada. This trial will provide evidence on the impact of ADT in romCSPC managed with optimal recurrence directed therapy. Findings will support phase III trial design to help define the optimal management of romCSPC in the future. Clinical trial information: NCT06654336 .
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 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 | 0.002 |
| Insufficient payload (model declined to judge) | 0.008 | 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".