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November 21, 2024
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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

Publicated to: LANCET. 404 (10459): 1227-1239 - 2024-09-28 404(10459), DOI: 10.1016/S0140-6736(24)01653-2

Authors:

Morris, MJ; Castellano, D; Herrmann, K; de Bono, JS; Shore, ND; Chi, KN; Crosby, M; Piulats, JM; Fléchon, A; Wei, XX; Mahammedi, H; Roubaud, G; Studentová, H; Nagarajah, J; Mellado, B; Montesa-Pino, A; Kpamegan, E; Ghebremariam, S; Kreisl, TN; Wilke, C; Lehnhoff, K; Sartor, O; Fizazi, K
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Affiliations

AU Clin, Carolina Urol Res Ctr - Author
BC Canc, Vancouver - Author
Catalan Inst Oncol - Author
Ctr Jean Perrin - Author
Ctr Leon Berard - Author
Dana Farber Canc Inst - Author
Hosp Univ 12 Octubre, Res Inst I 12, Med Oncol Dept - Author
Inst Bergonie - Author
Mayo Clin - Author
Mem Sloan Kettering Canc Ctr, Genitourinary Oncol Serv - Author
NCT West, Natl Ctr Tumor Dis - Author
Novartis Pharm AG - Author
Novartis Pharmaceut - Author
Palacky Univ, Univ Hosp, Fac Med & Dent, Dept Oncol - Author
Paris Saclay Univ, Gustave Roussy Inst - Author
Roentgeninst Dusseldorf - Author
Royal Marsden Hosp - Author
UGCI Hosp Univ Reg & Virgen Victoria Malaga, IBIMA - Author
Univ Barcelona, Hosp Clin Barcelona, Inst Invest Biomed Pi & Sunyer, Med Oncol Dept - Author
Vet Prostate Canc Awareness - Author
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Abstract

Background [Lu-177]Lu-PSMA-617 1 77Lu]Lu-PSMA-617 (Lu-177-PSMA-617) Lu-177-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 Lu-177-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, taxanenaive 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 Lu-177-PSMA-617 at a dosage of 74 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 Lu-177-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 Lu-177-PSMA-617 (234 [50%] patients) or ARPI change (234 [50%]). Baseline characteristics were mostly similar between groups; median number of Lu-177-PSMA-617 cycles was 60 (IQR 40-60). Of patients assigned to ARPI change, 134 (57%) crossed over to receive Lu-177-PSMA-617. In the primary analysis (median time from randomisation to first data cutoff 726 months [IQR 338-1055]), the median radiographic progression-free survival was 930 months (95% CI 677-not estimable) in the Lu-177-PSMA-617 group versus 555 months (404-595) in the ARPI change group (hazard ratio [HR] 041 [95% CI 029-056]; p
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Keywords

AbirateroneAdjuvant chemotherapyAdultAgedAlkaline phosphataseAndrogen receptor antagonistAndrogen receptor antagonistsAndrogen receptor pathway inhibitorAndrostane derivativeAndrostenesArticleBenzamide derivativeBenzamidesBloodCancer chemotherapyCancer gradingCancer growthCancer radiotherapyCastration resistant prostate cancerClinical outcomeClinical trialComputer assisted tomographyControlled clinical trialControlled studyDarolutamideDipeptideDipeptidesDisease exacerbationDocetaxelDrug efficacyDrug safetyDrug therapyEcog performance statusEnzalutamideFemaleFunctional assessmentGood clinical practiceHemoglobinHeterocyclic compounds, 1-ringHumanHumansLactate dehydrogenaseLutetiumLutetium 177Lutetium 177 psma 617Major clinical studyMaleMenMetastatic castration resistant prostate cancerMiddle agedMulticenterMulticenter studyNitrileNitrilesNuclear magnetic resonance imagingOpen-labelOverall survivalPathologyPhase 3 clinical trialPhenylthiohydantoinProgression free survivalProgression-free survivalProstate specific antigenProstate specific membrane antigenProstate-specific antigenProstatic neoplasms, castration-resistantProtein inhibitorQuality-of-lifeRadioisotopeRadioisotopesRandomized controlled trialSingle heterocyclic ringsStandardSurvivalTaxane derivativeTaxoidTaxoidsToxicitiesTreatment responseUnclassified drugVipivotide tetraxetan lutetium lu 177Vision

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal LANCET due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2024 there are still no calculated indicators, but in 2023, it was in position 1/332, thus managing to position itself as a Q1 (Primer Cuartil), in the category Medicine, General & Internal. Notably, the journal is positioned above the 90th percentile.

Independientemente del impacto esperado determinado por el canal de difusión, es importante destacar el impacto real observado de la propia aportación.

Según las diferentes agencias de indexación, el número de citas acumuladas por esta publicación hasta la fecha 2026-04-07:

  • WoS: 170
  • Scopus: 174
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Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2026-04-07:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 164.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 164 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 205.
  • The number of mentions on the social network Facebook: 1 (Altmetric).
  • The number of mentions on the social network X (formerly Twitter): 75 (Altmetric).
  • The number of mentions in news outlets: 23 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.
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Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Canada; Czech Republic; France; Germany; Netherlands; Switzerland; United Kingdom; United States of America.

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