TY - JOUR
T1 - Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer
T2 - the BULLSEYE trial
AU - Privé, Bastiaan M.
AU - Janssen, Marcel J.R.
AU - van Oort, Inge M.
AU - Muselaers, Constantijn H.J.
AU - Jonker, Marianne A.
AU - van Gemert, Willemijn A.
AU - de Groot, Michel
AU - Westdorp, Harm
AU - Mehra, Niven
AU - Verzijlbergen, J. Fred
AU - Scheenen, Tom W.J.
AU - Zámecnik, Patrik
AU - Barentsz, Jelle O.
AU - Gotthardt, Martin
AU - Noordzij, Walter
AU - Vogel, Wouter V.
AU - Bergman, Andries M.
AU - van der Poel, Henk G.
AU - Vis, André N.
AU - Oprea-Lager, Daniela E.
AU - Gerritsen, Winald R.
AU - Witjes, J. Alfred
AU - Nagarajah, James
N1 - Funding Information:
This study is funded by the Prostaatkankerstichting (Dutch prostate cancer foundation) and by Advanced Accelerator Applications, a Novartis Company. The granting will not have any role in the collection, analysis, and interpretation of data and in writing the manuscript.
Funding Information:
JN receives research support from ABX Pharmaceuticals and Advanced Accelerator Applications.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/11
Y1 - 2021/11
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85118722359&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05733-4
DO - 10.1186/s13063-021-05733-4
M3 - Article
C2 - 34736509
AN - SCOPUS:85118722359
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 768
ER -
