Lutetium-177-PSMA-I T as metastases directed therapy in oligometastatic hormone sensitive prostate cancer, a randomized controlled trial

Abstract Background In recent years, there is increasing evidence showing a beneficial outcome (e.g. progression free survival; PFS) after metastases-directed therapy (MDT) with external beam radiotherapy (EBRT) or targeted surgery for oligometastatic hormone sensitive prostate cancer (oHSPC). Howev...

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Published in:BMC cancer 2020-09, Vol.20 (1), p.1-9
Main Authors: Bastiaan M. Privé, Marcel J. R. Janssen, Inge M. van Oort, Constantijn H. J. Muselaers, Marianne A. Jonker, Michel de Groot, Niven Mehra, J. Fred Verzijlbergen, Tom W. J. Scheenen, Patrik Zámecnik, Jelle O. Barentsz, Martin Gotthardt, Walter Noordzij, Wouter V. Vogel, Andries M. Bergman, Henk G. van der Poel, André N. Vis, Daniela E. Oprea-Lager, Winald R. Gerritsen, J. Alfred Witjes, James Nagarajah
Format: Article
Language:English
Subjects:
Hormone sensitive prostate Cancer
Lutetium-177-PSMA
Metastases directed therapy
Oligometastases
Radioligand therapy
Urologic oncology
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Summary:Abstract Background In recent years, there is increasing evidence showing a beneficial outcome (e.g. progression free survival; PFS) after metastases-directed therapy (MDT) with external beam radiotherapy (EBRT) or targeted surgery for oligometastatic hormone sensitive prostate cancer (oHSPC). However, many patients do not qualify for these treatments due to prior interventions or tumor location. Such oligometastatic patients could benefit from radioligand therapy (RLT) with 177Lu-PSMA; a novel tumor targeting therapy for end-stage metastatic castration-resistant prostate cancer (mCRPC). Especially because RLT could be more effective in low volume disease, such as the oligometastatic status, due to high uptake of radioligands in smaller lesions. To test the hypothesis that 177Lu-PSMA is an effective treatment in oHSPC to prolong PFS and postpone the need for androgen deprivation therapy (ADT), we initiated a multicenter randomized clinical trial. This is globally, the first prospective study using 177Lu-PSMA-I&T in a randomized multicenter setting. Methods & design This study compares 177Lu-PSMA-I&T MDT to the current standard of care (SOC); deferred ADT. Fifty-eight patients with oHSPC (≤5 metastases on PSMA PET) and high PSMA uptake (SUVmax > 15, partial volume corrected) on 18F-PSMA PET after prior surgery and/or EBRT and a PSA doubling time of
ISSN:1471-2407
DOI:10.1186/s12885-020-07386-z