A prospective phase 2/3 multicenter study of <sup>18</sup>F-DCFPyL PET/CT imaging in patients with prostate cancer: Examination of diagnostic accuracy (OSPREY).
Bibliographic record
Abstract
TPS5092 Background: Accurate localization of sites of disease is essential for delivering optimal care to patients with prostate cancer. This is especially true for patients who may have distant disease either at initial staging or at relapse and may benefit from curative local primary or salvage treatments. 18F-DCFPyL (PyL) is a novel, high specific activity, highly selective, low-molecular weight prostate-specific membrane antigen (PSMA)-targeted PET radiopharmaceutical. This trial seeks to analytically validate the performance characteristics of PyL PET/CT for the detection of metastatic and/or recurrent prostate cancer. Methods: This is a multi-center, open-label, phase 2/3 study evaluating the diagnostic performance of PyL PET/CT in patients with at least high-risk (as defined by NCCN guideline v3.2016) prostate cancer prior to radical prostatectomy [cohort A] or radiologically confirmed metastatic/recurrent prostate cancer [cohort B]. A total of approximately 400 subjects will be enrolled in the study. All patients must be at least 18 years of age with histologically confirmed adenocarcinoma of the prostate. A single administration of PyL (9 ± 1 mCi [333 ± 37 MBq]) is administered 1-2 hours prior to PET/CT imaging on Day 1. The primary objective is to assess the diagnostic performance (sensitivity and specificity) of PyL PET/CT in the detection of metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in pre-prostatectomy patients [cohort A], as determined by independent central review. Key secondary objectives include safety and tolerability of PyL, diagnostic performance of PyL PET/CT in the detection of prostate cancer within sites of distant metastasis or local recurrence [cohort B], and pharmacokinetic parameters of PyL in a subset of subjects. The clinical impact of PyL PET/CT imaging on the intended management of prostate cancer patients will also be assessed as an exploratory endpoint. Clinical trial information: NCT02981368.
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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 | 0.009 | 0.004 |
| 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 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| 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".