TY - JOUR
T1 - Randomized Trial of Prostate-Specific Membrane Antigen PET/CT Before Definitive Radiotherapy for Unfavorable Intermediate- and High-Risk Prostate Cancer (PSMA-dRT Trial)
AU - Nikitas, John
AU - Lam, Ethan
AU - Booker, Kiara Adame
AU - Fendler, Wolfgang P.
AU - Eiber, Matthias
AU - Hadaschik, Boris
AU - Herrmann, Ken
AU - Hirmas, Nader
AU - Lanzafame, Helena
AU - Stuschke, Martin
AU - Czernin, Johannes
AU - Steinberg, Michael L.
AU - Nickols, Nicholas G.
AU - Kishan, Amar U.
AU - Calais, Jeremie
N1 - Publisher Copyright:
COPYRIGHT © 2024 by the Society of Nuclear Medicine and Molecular Imaging.
PY - 2024/7/1
Y1 - 2024/7/1
N2 - This multicenter randomized phase III trial (NCT04457245) evaluated the effect of performing prostate-specific membrane antigen (PSMA) PET/CT before definitive radiotherapy. Methods: Men with unfavorable intermediate- or high-risk prostate cancer were randomized 1.08:1 between receiving and not receiving a PSMA PET/CT scan before definitive radiotherapy. All other imaging modalities were allowed in the control arm. The primary endpoint was 5-y progression-free survival. Results: Fifty-four men were randomized between November 2020 and December 2021 (PSMA PET/CT, n 5 25; control, n 5 29). The trial closed early after approval and insurance coverage of PSMA PET/CT. In the PSMA PET/CT arm, 14 patients had localized disease (miT2b-cN0M0), 6 had locally advanced disease (miT3abN0M0), 3 had regional metastasis (miN1M0), and 1 had distant metastasis (miM1b). Four patients were upstaged. Conclusion: PSMA PET/CT upstaged 17% of patients, which allowed for more accurate radiotherapy planning. Unfortunately, this trial closed early before completion of target enrollment (54/316, 17%) and was underpowered to assess the effect of PSMA PET/CT on progression-free survival.
AB - This multicenter randomized phase III trial (NCT04457245) evaluated the effect of performing prostate-specific membrane antigen (PSMA) PET/CT before definitive radiotherapy. Methods: Men with unfavorable intermediate- or high-risk prostate cancer were randomized 1.08:1 between receiving and not receiving a PSMA PET/CT scan before definitive radiotherapy. All other imaging modalities were allowed in the control arm. The primary endpoint was 5-y progression-free survival. Results: Fifty-four men were randomized between November 2020 and December 2021 (PSMA PET/CT, n 5 25; control, n 5 29). The trial closed early after approval and insurance coverage of PSMA PET/CT. In the PSMA PET/CT arm, 14 patients had localized disease (miT2b-cN0M0), 6 had locally advanced disease (miT3abN0M0), 3 had regional metastasis (miN1M0), and 1 had distant metastasis (miM1b). Four patients were upstaged. Conclusion: PSMA PET/CT upstaged 17% of patients, which allowed for more accurate radiotherapy planning. Unfortunately, this trial closed early before completion of target enrollment (54/316, 17%) and was underpowered to assess the effect of PSMA PET/CT on progression-free survival.
KW - PET
KW - prostate cancer
KW - prostate-specific membrane antigen
KW - radiation therapy
KW - randomized clinical trial
UR - http://www.scopus.com/inward/record.url?scp=85198035537&partnerID=8YFLogxK
U2 - 10.2967/jnumed.123.267004
DO - 10.2967/jnumed.123.267004
M3 - Article
C2 - 38664019
AN - SCOPUS:85198035537
SN - 0161-5505
VL - 65
SP - 1076
EP - 1079
JO - Journal of Nuclear Medicine
JF - Journal of Nuclear Medicine
IS - 7
ER -
