PSMAddition: A phase 3 trial to compare treatment with <sup>177</sup>Lu-PSMA-617 plus standard of care (SoC) and SoC alone in patients with metastatic hormone-sensitive prostate cancer.
Bibliographic record
Abstract
TPS5116 Background: Lutetium (177Lu) vipivotide tetraxetan (177Lu-PSMA-617) plus protocol-permitted standard of care (SoC) significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer, previously treated with at least one androgen receptor pathway inhibitor (ARPI) and one or two taxanes. Androgen deprivation therapy (ADT) and ARPIs may alter PSMA expression and radiosensitivity. PSMAddition will assess the efficacy and safety of 177Lu-PSMA-617 plus 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, with crossover, in adults with mHSPC. Eligible patients are treatment-naive or minimally treated candidates for hormonal therapy, with PSMA-positive disease (determined by 68Ga-PSMA-11 PET/CT), ECOG 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 177Lu-PSMA-617 (7.4 GBq every 6 weeks for a maximum of 6 cycles) plus SoC or SoC alone (an ARPI and ADT). 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). Recruitment for a China extension cohort (40–60 patients) will follow after completion of main study recruitment. The primary endpoint is rPFS, as assessed by blinded independent centralized review. Upon centrally confirmed radiographic progression, participants in the SoC-only arm can cross over to the 177Lu-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 OS, others include 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 PFS (radiographic, clinical or PSA progression), safety and tolerability, and health-related quality of life. Imaging and biospecimen (tissue and blood) collection is embedded for correlative analysis. Participants who have received 177Lu-PSMA-617 will have the option to enroll in a separate long-term safety follow-up study. Updated from previous presentation at the 2021 European Society for Medical Oncology Congress, FPN 3035, with permission. Clinical trial information: NCT04720157 .
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.011 | 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".