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177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial
Open accessAbstract
Background [177 Lu]Lu-PSMA-617 (177 Lu-PSMA-617) prolongs radiographic progression-free survival and overall survival in patients with metastatic castration-resistant prostate cancer previously treated with androgen receptor pathway inhibitor (ARPI) and taxane therapy. We aimed to investigate the efficacy of 177 Lu-PSMA-617 in patients with taxane-naive metastatic castration-resistant prostate cancer.Methods In this phase 3, randomised, controlled trial conducted at 74 sites across Europe and North America, taxane-naive patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who had progressed once on a previous ARPI were randomly allocated (1:1) to open-label, intravenous 177 Lu-PSMA-617 at a dosage of 7·4 GBq (200 mCi) ± 10% once every 6 weeks for six cycles, or a change of ARPI (to abiraterone or enzalutamide, administered orally on a continuous basis per product labelling). Crossover from ARPI change to 177 Lu-PSMA-617 was allowed after centrally confirmed radiographic progression. The primary endpoint was radiographic progression-free survival, defined as the time from randomisation until radiographic progression or death, assessed in the intention-to-treat population. Safety was a secondary endpoint. This study is registered with ClinicalTrials.gov (NCT04689828) and is ongoing. In this primary report of the study, we present primary (first data cutoff) and updated (third data cutoff) analyses of radiographic progression-free survival; all other data are based on the third data cutoff.Findings Overall, of the 585 patients screened, 468 met all eligibility criteria and were randomly allocated between June 15, 2021 and Oct 7, 2022 to receive 177 Lu-PSMA-617 (234 [50%] patients) or ARPI change (234 [50%]). Baseline characteristics were mostly similar between groups; median number of 177 Lu-PSMA-617 cycles was 6·0 (IQR 4·0-6·0). Of patients assigned to ARPI change, 134 (57%) crossed over to receive 177 Lu-PSMA-617. In the primary analysis (median time from randomisation to first data cutoff 7·26 months [IQR 3·38-10·55]), the median radiographic progression-free survival was 9·30 months (95% CI 6·77-not estimable) in the 177 Lu-PSMA-617 group versus 5·55 months (4·04-5·95) in the ARPI change group (hazard ratio [HR] 0·41 [95% CI 0·29-0·56]; p<0·0001). In the updated analysis at time of the third data cutoff (median time from randomisation to third data cutoff 24·11 months [IQR 20·24-27·40]), median radiographic progression-free survival was 11·60 months (95% CI 9·30-14·19) in the 177 Lu-PSMA-617 group versus 5·59 months (4·21-5·95) in the ARPI change group (HR 0·49 [95% CI 0·39-0·61]). The incidence of grade 3-5 adverse events was lower in the 177 Lu-PSMA-617 group (at least one event in 81 [36%] of 227 patients; four [2%] grade 5 [none treatment related]) than the ARPI change group (112 [48%] of 232; five [2%] grade 5 [one treatment related]).Interpretation 177 Lu-PSMA-617 prolonged radiographic progression-free survival relative to ARPI change, with a favourable safety profile. For patients with PSMA-positive metastatic castration-resistant prostate cancer who are being considered for a change of ARPI after progression on a previous ARPI, 177 Lu-PSMA-617 may be an effective treatment alternative.Funding Novartis.
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“The findings in the third data cutoff point thus far showed that those in the experimental group exhibited a statistically significant improvement in rPFS compared to the ARPI change group (median 11.6 months vs 5.59 months; HR:0.49).”
From PSMA-based Therapies and Novel Therapies in Advanced Prostate Cancer: The Now and the Future (2025) · cites this paper as [14]
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“Preliminary safety analysis indicated that 177Lu-PSMA- 617 was generally well-tolerated with lower incidence of grade 3–5 adverse events as compared to control group, while OS data is still not fully mature”
From PSMA-based Therapies and Novel Therapies in Advanced Prostate Cancer: The Now and the Future (2025) · cites this paper as [14]
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Metadata
- Authors
- Morris, M. J., Castellano, D., Herrmann, K., de Bono, J. S., Shore, N. D., Chi, K. N., Crosby, M., Piulats, J. M., Fléchon, A., Wei, X. X., Mahammedi, H., Roubaud, G., Študentová, H., Nagarajah, J., Mellado, B., Montesa-Pino, Á., Kpamegan, E., Ghebremariam, S., Kreisl, T. N., Wilke, C., Lehnhoff, K., Sartor, O., & Fizazi, K.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- Research Institute Hospital 12 de Octubre (ES)
- National Center for Tumor Diseases (DE)
- Carolina Urologic Research Center (US)
- BC Cancer Agency (CA)
- Institut Català d'Oncologia (ES)
- Centre Léon Bérard (FR)
- Dana-Farber Cancer Institute (US)
- Centre Jean Perrin (FR)
- Institut Bergonié (FR)
- University Hospital Olomouc (CZ)
- Radboud University Medical Center (NL)
- Hospital Clínic de Barcelona (ES)
- Novartis (Switzerland) (CH)
- Mayo Clinic (US)
- Université Paris-Saclay (FR)
- Corresponding author
- Morris, Michael J
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2024-09
- Volume
- 404
- Issue
- 10459
- Pages
- 1227-1239
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC12121614
- OpenAlex
- W4402552580
- Cited by
- 362
- References
- 47
- Citations by year
- 2026: 204 · 2025: 150 · 2024: 8
- FWCI
- 104.54
- Type
- journal article
- Language
- en
- Update notices
- erratum (2024-12-21)
- Open access
- green
- pmc.ncbi.nlm.nih.gov
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Funders
- Novartis Pharmaceuticals Corporation
- Novartis
- National Institutes of Health
- National Cancer Institute (P30 CA008748)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Health Sciences › Medicine › Urology › Prostate Cancer Diagnosis and Treatment
- Keywords
- 177Lu-PSMA-617, androgen receptor pathway inhibitors, abiraterone, enzalutamide, radiographic progression-free survival, radiographic progression, overall survival, radioligand therapy
- MeSH terms
- Progression-Free Survival, Aged, Androstenes, Benzamides, Dipeptides, Heterocyclic Compounds, 1-Ring, Humans, Lutetium, Male, Middle Aged, Nitriles, Phenylthiohydantoin, Radioisotopes, Prostate-Specific Antigen, Taxoids, Androgen Receptor Antagonists, Prostatic Neoplasms, Castration-Resistant
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