20 Preliminary Results of a Two Stage Phase II Study of 18F-DCFPYL PET-MR for Enabling Oligometastases Ablative Therapy in Subclinical Prostate Cancer
Bibliographic record
Abstract
Purpose: Despite maximal local therapies (MLT) (radical prostatectomy followed by radiotherapy [RT]), 20-30% of men will have incurable progression of prostate cancer (PC).Most recurrences in this scenario are characterized by continuous PSA rises and failure of standard imaging (bone scan [BS] and computed tomography [CT]) to detect recurrence sites.We conducted a Phase II trial for men with rising PSA after MLT using 18F-DCFPyL PET-MR/CT followed by targeted ablation of PET positive foci.We report the results of our pre-defined analysis. Materials and Methods:Patients with rising PSA (0.4 -3.0 ng/ mL) after MLT, negative BS/CT and no prior salvage ADT were eligible.All patients underwent 18F-DCFPyL PET-MR followed by immediate PET-CT acquisition.Those with limited disease, where possible, underwent stereotactic ablative RT (SABR) or surgery.No ADT was used.The primary endpoint was biochemical response rate (complete [undetectable PSA] or partial [PSA decline ≥50% compared to baseline]).A Simon's two stage study design was employed.Stage 1 included 12 response-evaluable patients, requiring one or more responses in the absence of Grade 3+ toxicities to proceed to Stage 2 (additional 25 response-evaluable patients).Results: After a median of 58 months (range 29-120) post MLT, 20 patients underwent PET-MR/CT to have 12 response-evaluable patients.Median PSA at enrollment was 1.3 ng/mL (range 0.4-2.8).Three patients had negative PET-MR/CT, while 17 had positive scans, of which 12 (60%) were amenable to response-evaluable ablation.The median number of detected lesions in those treated was 2 (range 1-5).Ten patients underwent SABR (27-30 Gy / 3 fractions) and two had surgery.One patient (8%) had complete and four (33%) had partial PSA responses at a median of 3.3 months (range 2.8-6.0)after ablation, while the remaining seven (59%) did not have biochemical response.No Grade 3+ toxicities were observed.Conclusions: 18F-DCFPyL PET-MR/CT has high detection rates in men with rising PSA after MLT.We observed favorable early results with SABR or surgery (41% RR; no Grade 3+ toxicities).Accrual completion and preliminary results on the entire cohort are expected for Q1 and Q3 2019, respectively.Our study will uniquely inform if ablative approaches offer potential for cure in an early molecularly-defined PC oligometastatic state. 21
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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 | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 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".