Phase 3 multicenter randomized trial of PSMA PET/CT prior to definitive radiation therapy for unfavorable intermediate-risk or high-risk prostate cancer [PSMA dRT]: study protocol

Jeremie Calais, Shaojun Zhu, Nader Hirmas, Matthias Eiber, Boris Hadaschik, Martin Stuschke, Ken Herrmann, Johannes Czernin, Amar U Kishan, Nicholas G Nickols, David Elashoff, Wolfgang P Fendler, Jeremie Calais, Shaojun Zhu, Nader Hirmas, Matthias Eiber, Boris Hadaschik, Martin Stuschke, Ken Herrmann, Johannes Czernin, Amar U Kishan, Nicholas G Nickols, David Elashoff, Wolfgang P Fendler

Abstract

Background: Definitive radiation therapy (dRT) is an effective initial treatment of intermediate-risk (IR) and high-risk (HR) prostate cancer (PCa). PSMA PET/CT is superior to standard of care imaging (CT, MRI, bone scan) for detecting regional and distant metastatic PCa. PSMA PET/CT thus has the potential to guide patient selection and the planning for dRT and improve patient outcomes.

Methods: This is a multicenter randomized phase 3 trial (NCT04457245). We will randomize 312 patients to proceed with standard dRT (control Arm, n = 150), or undergo a PSMA PET/CT scan at the study site (both 18F-DCFPyL and 68Ga-PSMA-11 can be used) prior to dRT planning (intervention arm, n = 162). dRT will be performed at the treating radiation oncologist facility. In the control arm, dRT will be performed as routinely planned. In the intervention arm, the treating radiation oncologist can incorporate PSMA PET/CT findings into the RT planning. Androgen deprivation therapy (ADT) is administered per discretion of the treating radiation oncologist and may be modified as a result of the PSMA PET/CT results. We assume that approximately 8% of subjects randomized to the PSMA PET arm will be found to have M1 disease and thus will be more appropriate candidates for long-term systemic or multimodal therapy, rather than curative intent dRT. PET M1 patients will thus not be included in the primary endpoint analysis. The primary endpoint is the success rate of patients with unfavorable IR and HR PCa after standard dRT versus PSMA PET-based dRT. Secondary Endpoints (whole cohort) include progression free survival (PFS), metastasis-free survival after initiation of RT, overall survival (OS), % of change in initial treatment intent and Safety.

Discussion: This is the first randomized phase 3 prospective trial designed to determine whether PSMA PET/CT molecular imaging can improve outcomes in patients with PCa who receive dRT. In this trial the incorporation of PSMA PET/CT may improve the success rate of curative intent radiotherapy in two ways: to optimize patient selection as a biomarker and to personalizes the radiotherapy plan.

Clinical trial registration: UCLA IND#147591 ○ Submission: 02.27.2020 ○ Safe-to-proceed letter issued by FDA: 04.01.2020 UCLA IRB #20-000378 ClinicalTrials.gov Identifier NCT04457245 . Date of Registry: 07.07.2020. Essen EudraCT 2020-003526-23.

Keywords: Definitive radiation therapy; PET/CT; PSMA; Prostate cancer; Randomized phase 3 trial.

Conflict of interest statement

JCa reports prior consulting activities outside of the submitted work for Advanced Accelerator Applications, Blue Earth Diagnostics, Curium Pharma, GE Healthcare, Janssen, Progenics, Radiomedix and Telix pharmaceuticals.

SZ was a consultant for ABX and Sofie Biosciences, outside of the submitted work.

ME was a consultant for ABX, Blue Earth Diagnostics and Progenics and has patent rights on rhPSMA, outside of the submitted work.

BH reports personal fees from ABX, Bayer, Lightpoint Medical, Inc., Janssen R&D, Bristol-Myers-Squibb and Astellas and travel from AstraZeneca, Janssen R&D and Astellas.

KH is a board member, and holds equity in Sofie Biosciences. Intellectual property is patented by the University of California and licensed to Sofie Biosciences. KHe was a consultant for Advanced Accelerator Applications, Amgen, Bayer, Curium Pharma, GE Healthcare, IPSEN, Janssen Pharmaceuticals, BTG, Sirtex, Novartis, ROTOP, Bain Capital outside of the submitted work.

JCz is a founder, board member, and holds equity in Sofie biosciences and Trethera Therapeutics. Intellectual property is patented by the University of California and licensed to Sofie Biosciences and Trethera Therapeutics. No other potential conflict of interest relevant to this article was reported.

WF was a consultant for Endocyte and BTG, and he received fees from RadioMedix and Bayer outside of the submitted work.

Figures

Fig. 1
Fig. 1
Flowchart of literature search and selection of studies

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