Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer

Autor: Willemijn A. M. van Gemert, Andries M. Bergman, Constantijn H.J. Muselaers, Henk G. van der Poel, Walter Noordzij, André N. Vis, Patrik Zamecnik, Bastiaan M. Privé, Harm Westdorp, Inge M. van Oort, Michel de Groot, James Nagarajah, Martin Gotthardt, Marianne A. Jonker, Winald R. Gerritsen, Daniela E. Oprea-Lager, Niven Mehra, Wouter V. Vogel, Marcel J.R. Janssen, Jelle O. Barentsz, J. Alfred Witjes, J. Fred Verzijlbergen, Tom W. J. Scheenen
Přispěvatelé: ​Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), CCA - Cancer Treatment and quality of life, Urology, Radiology and nuclear medicine
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Male
Oncology
medicine.medical_specialty
Medicine (General)
Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2]
Medicine (miscellaneous)
Lutetium
Hormone-sensitive prostate cancer
urologic and male genital diseases
Update
law.invention
Androgen deprivation therapy
Prostate cancer
Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14]
R5-920
Randomized controlled trial
law
Internal medicine
Urological cancers Radboud Institute for Molecular Life Sciences [Radboudumc 15]
medicine
Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14]
Humans
Effective treatment
Pharmacology (medical)
Trial registration
Lutetium-177-PSMA
Radioisotopes
Metastases-directed therapy
business.industry
Androgen Antagonists
medicine.disease
Hormones
Women's cancers Radboud Institute for Health Sciences [Radboudumc 17]
Prostatic Neoplasms
Castration-Resistant
Hormone sensitive prostate cancer
Radioligand therapy
Urologic oncology
Urological cancers Radboud Institute for Health Sciences [Radboudumc 15]
business
Treatment Arm
Oligometastases
Zdroj: Trials, 22, 1
Trials, 22
TRIALS, 22. BMC
Trials, Vol 22, Iss 1, Pp 1-4 (2021)
Trials, 22(1):768. BioMed Central
Privé, B M, Janssen, M J R, van Oort, I M, Muselaers, C H J, Jonker, M A, van Gemert, W A, de Groot, M, Westdorp, H, Mehra, N, Verzijlbergen, J F, Scheenen, T W J, Zámecnik, P, Barentsz, J O, Gotthardt, M, Noordzij, W, Vogel, W V, Bergman, A M, van der Poel, H G, Vis, A N, Oprea-Lager, D E, Gerritsen, W R, Witjes, J A & Nagarajah, J 2021, ' Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer : the BULLSEYE trial ', Trials, vol. 22, no. 1, 768 . https://doi.org/10.1186/s13063-021-05733-4
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-021-05733-4
Popis: Background The BULLSEYE trial is a multicenter, open-label, randomized controlled trial to test the hypothesis if 177Lu-PSMA is an effective treatment in oligometastatic hormone-sensitive prostate cancer (oHSPC) to prolong the progression-free survival (PFS) and postpone the need for androgen deprivation therapy (ADT). The original study protocol was published in 2020. Here, we report amendments that have been made to the study protocol since the commencement of the trial. Changes in methods and materials Two important changes were made to the original protocol: (1) the study will now use 177Lu-PSMA-617 instead of 177Lu-PSMA-I&T and (2) responding patients with residual disease on 18F-PSMA PET after the first two cycles are eligible to receive additional two cycles of 7.4 GBq 177Lu-PSMA in weeks 12 and 18, summing up to a maximum of 4 cycles if indicated. Therefore, patients receiving 177Lu-PSMA-617 will also receive an interim 18F-PSMA PET scan in week 4 after cycle 2. The title of this study was modified to; “Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer” and is now partly supported by Advanced Accelerator Applications, a Novartis Company. Conclusions We present an update of the original study protocol prior to the completion of the study. Treatment arm patients that were included and received 177Lu-PSMA-I&T under the previous protocol will be replaced. Trial registration ClinicalTrials.gov NCT04443062. First posted: June 23, 2020.
Databáze: OpenAIRE
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