PSMAddition: A phase 3 trial to compare treatment with <sup>177</sup>Lu-PSMA-617 plus standard of care (SOC) versus SOC alone in patients with metastatic hormone-sensitive prostate cancer.
Bibliographic record
Abstract
TPS210 Background: [ 177 Lu]Lu-PSMA-617 ( 177 Lu-PSMA-617) is a high-affinity prostate-specific membrane antigen (PSMA)-targeted radioligand therapy that delivers β-particle radiation to PSMA-expressing cells and the surrounding microenvironment. Androgen receptor pathway inhibitors (ARPI) may alter PSMA expression and radiosensitivity. PSMAddition will assess the efficacy and safety of 177 Lu-PSMA-617 plus standard of care (SOC) versus SOC alone in adults with metastatic hormone-sensitive prostate cancer (mHSPC). Methods: PSMAddition ( NCT04720157 ) is an international, prospective, open-label, randomized, phase 3 trial in adults with mHSPC. Eligible patients are treatment-naïve or minimally treated candidates for hormonal therapy, with PSMA-positive disease (determined by [ 68 Ga]Ga-PSMA-11 PET/CT), Eastern Cooperative Oncology Group performance status of 0 to 2 and adequate major organ function. Patients are excluded if they have rapidly progressing tumors that require chemotherapy. Approximately 1126 patients will be randomized 1:1 to receive 177 Lu-PSMA-617 (7.4 GBq i.v. every 6 weeks, ≤6 cycles) plus SOC or SOC alone (control arm). SOC is ARPI and androgen deprivation therapy. Stratification factors are tumor volume (high/low), age (≥70/ < 70 years) and previous/planned prostatectomy or radiation treatment of the primary prostate tumor (yes/no). The primary endpoint is radiographic progression-free survival (rPFS), as assessed by blinded independent centralized review. Upon centrally confirmed radiographic progression, participants in the control arm can cross over to the 177 Lu-PSMA-617 arm. The planned sample size provides 95% power to detect a hazard ratio of 0.7 for rPFS after 418 events with an overall one-sided significance level of 0.025. The key secondary endpoint is overall survival. Other secondary endpoints are the proportion of patients with a prostate-specific antigen (PSA) decline of ≥90% from baseline, time to development of metastatic castration-resistant prostate cancer, composite progression-free survival (radiographic, clinical or PSA progression), safety and tolerability, and health-related quality of life. Previously presented at the 2021 European Society for Medical Oncology Congress, FPN 3035, Tagawa S et al. Reused with permission. Clinical trial information: NCT04720157.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".