Abstract 1658TiP
Background
177Lu-PSMA-617 is a ß-emitting radioligand therapy (RLT) with radiographic progression-free survival (rPFS) and overall survival (OS) benefit in castrate-resistant prostate cancer following taxane chemotherapy. The trial tests an upfront accelerated dose schedule for 177Lu-PSMA-617, in addition to standard of care (SoC).
Trial design
STAMPEDE2 is a phase III, randomised, open label, multi-centre platform protocol testing treatments in patients with metastatic PC starting ADT (NCT06320067, ISRCTN66357938). For the 177Lu-PSMA-617 trial, eligibility is confirmed on conventional imaging with CT/MRI and Bone scan (Table). Patients are randomised (1:1 allocation) to arm A (SoC) or arm P (SoC + 177Lu-PSMA-617). SoC includes long-term ADT, androgen receptor signalling inhibitor (ARSI), ± prostate radiotherapy, ± docetaxel as part of ‘triplet therapy’. 177Lu-PSMA-617 is given at 7.4 GBq on day 1 and day 8, 3x 6-weekly cycles. An embedded imaging sub-study will evaluate 177Lu-PSMA-617 treatment response and dose uptake by tumour and normal tissue. The imaging sub-study includes paired PSMA PET/CT and Whole-Body MRI scans at baseline, after 2 cycles, and end of 177Lu-PSMA-617 treatment as well as three timepoint dosimetry studies per 177Lu-PSMA-617 dose. Biomarker testing is offered to all eligible patients. Patients with positive biomarker status are offered a second randomisation into the STAMPEDE2 Niraparib trial. Target recruitment is 1876 patients with dual primary outcomes of rPFS and OS. The target HR is 0.7 for rPFS and 0.75 for OS (90% overall pairwise power). The 177Lu-PSMA-617 trial within the STAMPEDE2 platform protocol is funded by AAA/Novartis, sponsored by University College London (UCL), and co-ordinated by the MRC CTU at UCL. Table: 1658TiP
| Key inclusion criteria | SABR-ineligible |
Clinical trial identificationNCT06320067, ISRCTN66357938. Editorial acknowledgementLegal entity responsible for the studyUniversity College London. FundingAAA/Novartis. DisclosureC. Jones: Financial Interests, Institutional, Speaker, Consultant, Advisor: BAYER, Janssen, Accord; Financial Interests, Institutional, Funding: BAYER. W. Cross: Financial Interests, Personal, Speaker, Consultant, Advisor: AAA/Novartis, Janssen, Bayer, Astellas, Ipsen, Myriad Genetics, Allied Healthcare; Financial Interests, Institutional, Research Grant: AAA/Novartis, Janssen, Bayer, Astellas, Ipsen, Myriad Genetics. M.K. Parmar: Financial Interests, Institutional, Full or part-time Employment, Director at MRC Clinical Trials Unit at UCL: Medical Research Council Clinical Trials Unit at UCL; Financial Interests, Personal and Institutional, Research Grant: AstraZeneca, Astellas, Janssen, Baxter, GSK; Financial Interests, Institutional, Research Grant: Clovis, Abcodia Pvt Ltd., Akagera, Amgen, Aspirin Foundation, Bayer, BMS US, Bri-BioCepheid, Cipla, CSL Behring, Eli Lilly, Emergent Biosolutions, Gilead Sciences, Grifols, Johnson & Johnson, Pfizer, Sanofi, ViiVHealthcare, Micronoma, Modus Theraputics, Mylan, Serum Institute of India, shionogi, SyntenyBiotechnology, Takeda, Tibotec, Transgene, Virco and Xenothera; Non-Financial Interests, Advisory Role, Euro Ewing Consortium: University College London; Non-Financial Interests, Advisory Role, rEECur: University of Birmingham; Non-Financial Interests, Advisory Role, CompARE Trial: University of Birmingham; Non-Financial Interests, Advisory Role, ROSSINI Trial Platform: University of Birmingham. S. Gillessen: Financial Interests, Institutional, Advisory Board, 2022: Amgen, AstraZeneca, Bayer, MSD Merck Sharp & Dohme, Myriad Genetic, Orion; Financial Interests, Institutional, Advisory Board, 2023: BMS, Daiichi Sankyo, Innomedica, Ipsen, Boehringer Ingelheim, Innomedica, Bayer; Financial Interests, Institutional, Invited Speaker, 2022: ESMO, Silvio Grasso Consulting; Financial Interests, Institutional, Other, Interview 2022: PeerVoice; Financial Interests, Institutional, Invited Speaker, 2023: SAKK, Meister ConCept GmbH, ASCO GU, EPG Health, S. Grasso Consulting, AdMeTech Foundation; Financial Interests, Institutional, Other, Faculty activity 2022: WebMD-Medscape; Financial Interests, Personal, Other, Travel support 2022: AstraZeneca; Financial Interests, Personal, Invited Speaker, 2022: DESO, SAKK; Financial Interests, Personal, Other, Travel support 2023: Bayer; Financial Interests, Institutional, Invited Speaker, 2024: Intellisphere LLC; Financial Interests, Personal, Other, Travel support 2024: Gilead; Financial Interests, Personal, Invited Speaker, Speaker OncoSummit 02.2024: Meister ConCept GmbH; Financial Interests, Personal, Other, Travel Support 2024: Intellisphere LLC; Financial Interests, Institutional, Other, Scientific Committee Pfizer Forschungspreis 2022/2023: Pfizer; Financial Interests, Institutional, Other, Consulting Agreement: TOLREMO; Financial Interests, Personal, Invited Speaker, 2023/2024: ESMO; Financial Interests, Institutional, Advisory Board, 2024: Ipsen, Macrogenics; Financial Interests, Personal, Other, Part of a patent for a biomarker, but (for the moment) no income, but I could not write none in the dropdown menu: Proteomedix/Onconetix; Financial Interests, Institutional, Funding, 2021, Unrestricted grant for a Covid related study as co-investigator: Astellas; Non-Financial Interests, Advisory Role, Continuing: ProteoMediX. G. Attard: Financial Interests, Personal, Invited Speaker: Janssen, Astellas, AstraZeneca; Financial Interests, Personal, Advisory Board: Janssen, Astellas, Novartis, Bayer, AstraZeneca, Pfizer, Sanofi, Sapience, Orion, Novartis, Blue Earth Therapeutics; Financial Interests, Personal, Royalties, Included in list of rewards to discoverers of abiraterone: Institute of Cancer Research; Financial Interests, Institutional, Advisory Board: Artera, Veracyte; Financial Interests, Institutional, Research Grant: Janssen, Astellas, Novartis; Financial Interests, Institutional, Coordinating PI: Janssen; Financial Interests, Institutional, Local PI: Novartis, Pfizer; Non-Financial Interests, Principal Investigator: Janssen, Astellas; Non-Financial Interests, Advisory Role: Janssen, AstraZeneca; Non-Financial Interests, Project Lead: Artera, Veracyte. C. Parker: Financial Interests, Personal, Advisory Board, Oct 2021: ITM Oncologics; Financial Interests, Institutional, Advisory Board, Dec 2021: AAA; Financial Interests, Personal, Advisory Board, May 2023: Blue Earth Therapeutics. N.D. James: Financial Interests, Personal, Advisory Board, Advice around PARP inhibitors: AstraZeneca; Financial Interests, Personal, Advisory Board, Prostate cancer therapies: Janssen, Clovis, Novartis; Financial Interests, Institutional, Advisory Board, Assisted with submissions regarding licencing for abiraterone: Janssen; Financial Interests, Personal, Advisory Board, Docetaxel: Sanofi; Financial Interests, Institutional, Advisory Board, Providing STAMPEDE trial data to facilitate licence extensions internationally for docetaxel: Sanofi; Financial Interests, Personal, Advisory Board, Bladder cancer therapy: Merck; Financial Interests, Personal, Advisory Board, Advice around novel hormone therapies for prostate cancer: Bayer; Financial Interests, Personal, Invited Speaker, Lecture tour in Brazil August 2022 - speaking on therapy for advanced prostate cancer: Merck Sharp & Dohme (UK) Limited; Financial Interests, Institutional, Coordinating PI, Funding for STAMPEDE trial: Janssen, Astellas; Financial Interests, Institutional, Coordinating PI, Funding for RADIO trial bladder cancer: AstraZeneca. All other authors have declared no conflicts of interest. 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