PT  - JOURNAL ARTICLE
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
TI  - Randomized Trial of Prostate-Specific Membrane Antigen PET/CT Before Definitive Radiotherapy for Unfavorable Intermediate- and High-Risk Prostate Cancer (PSMA-dRT Trial)
AID  - 10.2967/jnumed.123.267004
DP  - 2024 Jul 01
TA  - Journal of Nuclear Medicine
PG  - 1076--1079
VI  - 65
IP  - 7
4099  - http://jnm.snmjournals.org/content/65/7/1076.short
4100  - http://jnm.snmjournals.org/content/65/7/1076.full
SO  - J Nucl Med2024 Jul 01; 65
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 = 25; control, n = 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 (miT3a-bN0M0), 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.