Raadpleeg ook de lijst van niet-toxische ondersteuning bij prostaatkanker van arts-bioloog drs. Engelbert Valstar.
En als donateur kunt u ook korting krijgen bij verschillende bedrijven, waaronder bij Medpro voor o.a. prostasol een veel gebruikt natuurlijk middel bij prostaatkanker als alternatief voor hormoontherapie.
19 november 2025: Bron: ESMO 2025177Lu-PSMA-617 toegevoegd aan hormoontherapie plus een hormoon receptorremmer (ARPI) (ARPI zijn abirateron, enzalutamide, apalutamide en darolutamide o.a. ) geeft langere ziekteprogressievrije overleving bij patiënten met hormoongevoelige uitgezaaide prostaatkanker in vergelijking met een groep patiënten die geen 177Lu-PSMA-617 kregen naast hun hormoontherapie plus ARPI. Dat blijkt uit de resultaten van de gerandomiseerde PMSAddition fase III studie bij totaal 1144 patiënten gelijk verdeeld over 2 groepen.
Aan de studie namen 1144 patiënten (N = 572 vs 572) met hormoongevoelige uitgezaaide prostaatkanker die nog geen behandeling voor deze ziekte hadden ontvangen, of die een minimale behandeling hadden gekregen. Een strikte voorwaarde was dat de ziekte PSMA-positief was, gedefinieerd als ten minste één PSMA-positieve uitzaaiing op de 68Ga-PSMA-11 PET/CT-scan. Het primaire eindpunt van de studie was ziekteprogressievrije overleving (rPFS). Patiënten in de controlegroep konden overstappen naar de andere groep na bevestigde progressie van hun ziekte.
- Na een mediane follow-up van 23,6 maanden was de ziekteprogressievrije overleving (rPFS) significant langer in de 177Lu-PSMA-617 -groep, met een 28% lager risico op progressie van de ziekte in vergelijking met de controlegroep.
- De mediane ziekteprogressievrije overleving (rPFS) was in beide groepen nog niet bereikt, maar het aantal gebeurtenissen was significant lager in de interventiegroep (24,3 versus 30,1%; HR = 0,72). Alle subgroepen uit de studie profiteerden van de toevoeging van 177Lu-PSMA-617.
- De mediane overall overleving was in beide groepen ook nog niet bereikt en er waren onvoldoende sterfgevallen om de overleving te analyseren. Er werd echter een positieve trend waargenomen richting verbeterde overleving (HR = 0,84; p = 0,125). Andere eindpunten, zoals respons (85,3 versus 80,8%) en tijd tot PSA-progressie, waren ook verbeterd met 177Lu-PSMA-617.
Het abstract van de studie werd op ESMO 2025 gepresenteerd:
Phase III trial of Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormonesensitive prostate cancer (PSMAddition)
S.T. Tagawa 1 , O. Sartor 2 , J.M. Piulats 3 , F. Saad 4 , K. Fizazi 5 , A.H.M. Reid 6 , H. Beltran 7 , G. Kramer 8 , H. Mahammedi 9 , M. Eiber 10 , S. Gupta 11 , D.E. Castellano Gauna 12 , R. Hauke 13 , H. Kim14 , C. Kwak 15 , S-T. Pang 16 , E. Bouillaud 17 , A. Zhang 18 , O. Sakharova 18 , M.J. Morris 19 1 Hematology and Medical Oncology Dept., Weill Cornell Medicine, New York, United States of America, 2 Transformational Prostate Cancer Research Center, LCMC Health, New Orleans, United States of America, 3 Dept. Medical Oncology, Institut Catala d'Oncologia, Hospitalet de Llobregat, Spain, 4 Department of Surgery, The University of Montreal Hospital Center, Montreal, Canada, 5 Cancer Medicine Department, Institut Gustave Roussy, Centre Oscar Lambret, University of Paris-Saclay, Villejuif, France, 6 Uro-Oncology, The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom, 7 Division of Medical Oncology, Dana Farber Cancer Institute, Boston, United States of America, 8 Department of Urology, Medical University of Vienna, Vienna, Austria, 9 Department of Medical Oncology, Centre Jean Perrin, ClermontFerrand, France, 10 Department of Nuclear Medicine, Technical University of Munich (TUM), Munich, Germany, 11 Medicine Department, Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, United States of America, 12 Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain, 13 Medical Oncology, Nebraska Cancer Specialists, Omaha, United States of America, 14 Department of Radiation Oncology, Washington University School of Medicine, St. Louis, United States of America, 15 Urology, Seoul National University Hospital, Seoul, Republic of Korea, 16 Urology Department, Chang Gung Memorial Hospital at Linkou, Taoyuan City, Taiwan, 17 Biostatistics, Novartis Pharmaceuticals AG, Basel, Switzerland, 18 Clinical Development, Novartis Pharmaceuticals AG, Basel, Switzerland 19 Medicine Dept, Memorial Sloan Kettering Cancer Center, New York, United States of America
Background
ADT + androgen receptor pathway inhibitor (ARPI) is a standard of care for mHSPC but outcomes remain suboptimal. PSMAddition (NCT04720157) evaluates [ 177Lu]Lu-PSMA-617 ( 177Lu-PSMA-617) combined with ADT + ARPI in PSMA+ mHSPC.
Methods
Eligible adults had treatment-naïve/minimally treated (≤45 days) mHSPC and ≥1 PSMA+ metastatic lesion on [ 68Ga]Ga-PSMA-11 PET/CT. Randomization was 1:1 to open-label 177Lu-PSMA-617 (7.4 GBq q6w, 6 cycles) + ADT + ARPI ( 177Lu-PSMA-617 arm) or ADT + ARPI (control arm), stratified by disease volume (high/low), age (≥/<70 years) and previous/planned primary tumor treatment (yes/no). Control arm patients with centrally confirmed rPD could cross over to 177Lu-PSMA-617 if eligible. The primary endpoint was rPFS (per centrally assessed PCWG3 RECIST v1.1 or death); secondary endpoints included OS (key), ORR, safety/tolerability and QoL. We report rPFS interim analysis (IA) 2, the first efficacy IA.
Results
1144 patients were randomized (de novo mHSPC, 50.0%; high-volume disease, 68.1%). Baseline characteristics were balanced between arms. At rPFS IA2 (median study follow-up, 23.6 months; 177Lu-PSMA-617 cycles, 6 in 85.6% and ≥4 in 93.1%), the primary endpoint was met, with significantly improved rPFS (Table). There was a positive trend in intent-to-treat OS; ORR favored the 177Lu-PSMA-617 arm (Table). Overall incidence of AEs was slightly higher with addition of 177Lu-PSMA-617 (Table). Dry mouth was the most common AE (all grade 1–2; 177Lu-PSMA-617 vs control arm: 41.0% vs 3.4 % grade 1, 4.8% vs 0.4% grade 2). Grade ≥3 cytopenias were more frequent with added 177Lu-PSMA-617 (14.4% vs 5.0%). Time to worsening in QoL (FACT-P, EQ-5D) did not differ meaningfully between arms.
Conclusions
Combining 177Lu-PSMA-617 with ADT + ARPI significantly improved rPFS in this first phase 3 trial of radioligand therapy in mHSPC. Safety findings were consistent with the known profile and QoL was not adversely affected. Clinical trial identification NCT04720157. Editorial acknowledgement Under the guidance of the authors, Dr Shufei Song from Oxford PharmaGenesis provided medical writing support for this abstract, with funding from Novartis. Legal entity responsible for the study Novartis.
Funding Novartis. Disclosure S.T. Tagawa: Financial Interests, Personal, Advisory Board, Consultant: Convergent Therapeutics; Financial Interests, Personal, Other, Consultant: Ambrx, Telix Pharma, Blue Earth Diagnostics, POINT Biopharma, Myovant, Bayer, 4D Pharma, Gilead, Pfizer, Janssen, Astellas, AbbVie, Novartis, Seagen, Clarity, Merck, EMD Serono, Regeneron, Daiichi Sankyo, General Electric, Abdera; Financial Interests, Personal, Advisory Board: AIkido Pharma; Financial Interests, Personal, Other, DSMB: Boston Scientific, Boston Scientific; Financial Interests, Personal, Stocks/Shares, Options: AIkido Pharma, Convergent Therapeutics; Financial Interests, Personal, Other, Patent co-inventor: Gilead; Financial Interests, Institutional, Advisory Board, Patent: Convergent Therapeutics; Financial Interests, Personal, Advisory Board, Patent: Convergent Therapeutics; Financial Interests, Institutional, Local PI: Medivation, Astellas, Janssen, Amgen, BMS, AstraZeneca, Bayer, Merck, Clovis, Seagen, Janux, AIQ; Financial Interests, Institutional, Steering Committee Member: Gilead, Novartis, Point Biopharma, Clarity, Ambrx, Promontory, Telix. O. Sartor: Financial Interests, Institutional, Research Grant: Amgen, Bayer, Endocyte, Invitae, Progenics, Tenebio, Norroy Bioscience; Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca, Merck, Pfizer; Financial Interests, Personal and Institutional, Research Grant: AstraZeneca, Janssen, Lantheus, Merck, Novartis, Advanced Accelerator Applications; Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor: AstraZeneca, Janssen, Merck, Novartis, Artbio, Blue Earth Diagnostics, Clarity Pharmaceuticals, Fusion, Isotopen Technologien Muenchen, ModeX Therapeutics, Myovant, Myriad, Noria Therapeutics, Pfizer, Point BioPharma, Precede Biosciences, Sanofi, Telix; Financial Interests, Institutional, Speaker, Consultant, Advisor: Bayer, Tenebio; Financial Interests, Personal and Institutional, Other, travel and accommodation expenses: Lantheus; Financial Interests, Personal and Institutional, Other, travel and accommodation expenses : Novartis; Financial Interests, Personal, Stocks or ownership: Artbio, Clarity Pharmaceuticals, Fusion, Pfizer, Telix, Convergent, Lilly, Ratio, Cardinal Health, AbbVie, United Health Group ; Financial Interests, Personal, Speaker, Consultant, Advisor: North Star, Astellas Pharma, Dendreon, EMD Serono, MacroGenics, Progenics, Swiss Rockets; Financial Interests, Personal, Other, travel and accommodation expenses: North Star; Financial Interests, Personal, Expert Testimony: Sanofi. J.M. Piulats: Financial Interests, Personal, Advisory Board: Janssen, Astellas, Roche, BMS, MSD, BeiGene, VCN, AstraZeneca, Immunocore, Novartis; Financial Interests, Personal and Institutional, Research Grant: BMS, Pfizer, Janssen, BeiGene, Mirati, Immunocore, Regeneron. F. Saad: Financial Interests, Personal, Advisory Board: Astellas, Bayer, BMS, Janssen, Pfizer, Novartis, AstraZeneca, Merck, Sumitomo; Financial Interests, Institutional, Local PI: Novartis, Astellas, bayer, janssen, sanofi, bms, pfizer, Merck; Financial Interests, Institutional, Coordinating PI: AstraZeenca; Non-Financial Interests, Principal Investigator: Bayer, AstraZeneca, Novartis, AbbVie. K. Fizazi: Financial Interests, Institutional, Advisory Board: Astellas, Bayer, Janssen, MSD, AstraZeneca, Novartis/AAA, Pfizer, Daiichi Sankyo; Financial Interests,
Institutional, Invited Speaker: Astellas, Bayer, Janssen, MSD, AstraZeneca, Novartis, Pfizer; Financial Interests, Personal, Invited Speaker: Hopes, Tactics, PeerVoice, Research to Practice, Epics, Urotoday, ED Med resources, Medscape, Health podcast, Clinical care options, Oseus, e-china health, Darman Strategik Numerik, Cancerodigest; Financial Interests, Personal, Other, Comments on new data: Cancer expert now; Financial Interests, Personal, Advisory Board: Axiom, Arivan, Access infinity, Globe life sciences, Reach market research, MD to market, PSI; Financial Interests, Institutional, Research Grant, Trial chair: Pfizer, Bayer, AstraZeneca, Orion, MSD, BMS, Janssen; Financial Interests, Institutional, Coordinating PI, Trial chair: Novartis; Non-Financial Interests, Principal Investigator, Chair of the 7DX phase 3 trial: BMS; NonFinancial Interests, Principal Investigator, Chair of the Docetaxel-pembrolizumab phase 3 trial: Merck; Non-Financial Interests, Principal Investigator, Chair of the Darolutamide BCR phase 3 trial: Bayer; Non-Financial Interests, Principal Investigator, Chair of the PSMAfore phase 3 trial: AAA/Novartis; Non-Financial Interests, Principal Investigator, Chair of the CYPIDES ODM-208 Phase I-II trial: Orion; Non-Financial Interests, Principal Investigator, Chair of the STESIDES ODM-209 Phase I-II trial: Orion; Non-Financial Interests, Principal Investigator, Chair of the CAPITELLO 281 phase 3 trial: AstraZeneca; Non-Financial Interests, Principal Investigator, Chair of the TALAPRO-2 and TALAPRO-3 phase 3 trials: Pfizer; Non-Financial Interests, Principal Investigator, Chair of the RADIANT phase 3 trial: Bayer; Non-Financial Interests, Principal Investigator, Chair of the TRITON-3 phase 3 trial: Clovis. A.H.M. Reid: Financial Interests, Personal, Invited Speaker, Invited speaker at Janssen prostate meeting: Janssen; Financial Interests, Personal, Advisory Board: National Institute of Clinical Excellence; Financial Interests, Personal, Advisory Board, PSMA addition trial steering group member: Novartis; Financial Interests, Personal, Invited Speaker, Spouse (member of household): Janssen, Astellas, AstraZeneca, Pfizer, Blue Earth Therapeutics, Bayer, Novartis, Propella; Financial Interests, Personal, Invited Speaker, Spouse (Member of household): Arvinas; Financial Interests, Personal, Ownership Interest, Spouse has a patent on blood methylation markers (GB1915469.9) that is out licensed to a company spin-out that he co-founded (Cantor).: Cantor; Financial Interests, Personal, Other, Spouse is on the Institute of Cancer Research rewards to investors list for abiraterone. The Institute of Cancer Research, receives royalty income from abiraterone and spouse receives a share of this income through the Institute’s Rewards to Discoverers Scheme: Institute of Cancer Research; Financial Interests, Institutional, Local PI, Capitello in HSPC study- Local PI: AZD; Financial Interests, Institutional, Local PI, Amplitude clinical trial- Local PI: Janssen; Financial Interests, Institutional, Coordinating PI, Spouse receives research funding: Janssen, Astellas, Novartis; Financial Interests, Institutional, Research Grant, Spouse has an unrestricted research award from Agilent.: Agilent. H. Beltran: Financial Interests, Personal, Advisory Board: Pfizer, Janssen, AstraZeneca, Amgen, Diaachi Sankyo, Merck, Sanofi, Novartis; Financial Interests, Institutional, Funding: Bristol Myers Squibb,; Financial Interests, Institutional, Research Grant: Diaachi Sankyo, Circle Pharma, Novartis. G. Kramer: Financial Interests, Personal, Advisory Board: Accord, AstraZeneca, Bayer, BMS, Ferring, Ipsen, J&J, MSD, Novartis, Pfizer, Takeda; Financial Interests, Personal, Other, Lectures: Accord, Astellas, AstraZeneca, Bayer, BMS, Ferring, Ipsen, J&J, MSD, Novartis, Pfizer , Takeda; Financial Interests, Personal, Advisory Role: Astellas. H. Mahammedi: Financial Interests, Personal, Advisory Board: BMS, Bayer, Janssen, MSD, Astellas, Pfizer, Eisai, Novartis; Financial Interests, Personal, Invited Speaker: novartis, amgen, Eisai, Curium, Advanced Accelerator Applications; Financial Interests, Institutional, Advisory Board: merck; Financial Interests, Personal, Steering Committee Member: curium; Non-Financial Interests, Principal Investigator: BMS, Janssen, Roche, MSD, Pfizer, Novartis, Curium, Exelixis, AstraZeneca, Novartis, Debiopharm, Astellas. M. Eiber: Financial Interests, Institutional, Research Grant: Blue Earth Diagnostics; Financial Interests, Institutional, Speaker, Consultant, Advisor: Blue Earth Diagnostics, RayzeBio; Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor: Novartis; Financial Interests, Personal and Institutional, Invited Speaker: Novartis; Financial Interests, Personal, Speaker, Consultant, Advisor: Telix, Bayer, Point Biopharma, Janssen Pharmaceuticals; Financial Interests, Personal, Research Grant: Bayer; Financial Interests, Institutional, Invited Speaker: Eckert-Ziegler, ABX GmbH; Financial Interests, Personal, Invited Speaker: Janssen Pharmaceuticals; Financial Interests, Personal, Other, Image review: Parexel, Bioclinica; Financial Interests, Personal and Institutional, Royalties: POSLUMA® . S. Gupta: Financial Interests, Personal, Speaker, Consultant, Advisor: Merck, Bristol Myers Squibb, AstraZeneca, Novartis, Foundation Medicine, Gilead, Astellas ; Financial Interests, Institutional, Principal Investigator: Merck, Bristol Myers Squibb, Novartis, Convergent Therapeutics, Tyra Biosciences, Flare Therapeutics . D.E. Castellano Gauna: Financial Interests, Personal, Advisory Board: Pfizer, Roche, BMS, Janssen, Astellas, MSD, Ipsen, AstraZeneca, Novartis, GSK; Financial Interests, Institutional, Local PIadvisor/consultant: Pfizer, Roche, MSD, BMS, AstraZeneca, Janssen, Astellas, Ipsen, Exelisis, Eisai, Lilly, Bayer, GSK, Clovis, QED Therapeutics; Financial Interests, Personal and Institutional, Other, advisor/consultant: Novartis; Non-Financial Interests, Other, any: Associate Professor of Medical Oncology/Internal Medicine department; Non-Financial Interests, Personal, Other, Executive member: SOGUG (Spanish Oncology Genito-Urinary Group) Foundation; Non-Financial Interests, Personal, Training, Head of GU Alliance for Research and Development Consortium: GUARD Consortium; Other: Member of the Internal/local Pharmacy Commission at the Hospital Universitario 12 de Octubre. H. Kim: Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor: Novartis, BET; Financial Interests, Personal and Institutional, Research Funding: Novartis, BET. S. Pang: Financial Interests, Personal and Institutional, Principal Investigator: Novartis , Bayer, AstraZeneca, Pfizer, Janssen (J&J); Financial Interests, Personal and Institutional, Invited Speaker: Novartis ; Financial Interests, Personal, Full or part-time Employment: Chang Gung Memorial Hospital; Financial Interests, Personal and Institutional, Research Grant: National Science and Technology Council (Taiwan). E. Bouillaud, A. Zhang, O. Sakharova: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares: Novartis. M.J. Morris: Financial Interests, Personal, Advisory Board: AMBRX, Amgen, Arvinas, AstraZeneca, BMS Celgene, Blue Earth Diagnostics, Clarity Pharmaceuticals, Convergent, Curium, Daiichi, Exelixis, Flare Therapeutics, Fusion Pharmaceuticals, GSK, Lantheus, Molecular Partners, POINT Biopharma, Telix, Transtherabio, Z-alpha; Financial Interests, Personal, Other, Scientific Advisory Committee: Advancelle, LinkinVax, Wren Labaratories; Financial Interests, Personal, Other, Scientific Advisory Board: Convergent; Financial Interests, Personal, Invited Speaker: ITM Isotope Technologies, Progenics; Financial Interests, Institutional, Officer, Scientific Oversight Committee Chair: Prostate Cancer Clinical Consortium; Financial Interests, Personal, Stocks/Shares, 250 shares: Doximity; Financial Interests, Institutional, Advisory Board: Telix; Financial Interests, Institutional, Coordinating PI: Novartis, Celgen; Financial Interests, Institutional, Local PI: Corcept, Janssen, Astellas; Financial Interests, Institutional, Trial Chair, Institutional contract: Fusion; Non-Financial Interests, Advisory Role: Bayer, Janssen Oncology, Novartis; Other, Other, Travel/lodging at conference: APCCC. All other authors have declared no conflicts of interest. © European Society for Medical Oncology
Gerelateerde artikelen
- 177Lu-PSMA-617 naast hormoontherapie plus een hormoonreceptorremmer (ARPI) verlengt aantoonbaar de ziekteprogressievrije overleving bij mannen met uitgezaaide hormoongevoelige prostaatkanker
- 177Lu-PSMA-617 geeft betere progressievrije overleving en algehele overleving naast standaardzorg bij patiënten met gevorderde PSMA-positieve gemetastaseerde castratieresistente prostaatkanker
- lutetium-177 PSMA-617 gerichte bestralingsbehandeling geeft verdubbeling van ziekteprogressievrije tijd in vergelijking met abiraterone of enzalutamide bij patienten met uitgezaaide hormoonresistente prostaatkanker die nog geen chemo hadden gehad
- lutetium-177 PSMA-617 gerichte bestralingsbehandeling geeft alsnog uitstekende resultaten op overall overleving (plus 33 maanden) bij patienten met uitgezaaide hormoonresistente prostaatkanker.
- PSMA - Prostate Specific Membrane Antigen samen met pet / CT scan blijkt succesvolle behandeling voor hormoonresistente prostaatkankerpatienten met oplopende PSA
- PSMA gerichte PET scan bij mannen met verhoogde PSA is effectieve manier in ontdekken van plaats van tumoren. Bij uitzaaiingen op afstand heeft bestralen van bekkengebied geen zin.
Plaats een reactie ...
Reageer op "177Lu-PSMA-617 naast hormoontherapie plus een hormoonreceptorremmer (ARPI) verlengt aantoonbaar de ziekteprogressievrije overleving bij mannen met uitgezaaide hormoongevoelige prostaatkanker"