A prospective randomized multicentre study of the impact of gallium-68 prostate-specific membrane antigen (PSMA) PET/CT imaging for staging high-risk prostate cancer prior to curative-intent surgery or radiotherapy (proPSMA study): clinical trial protocol.

BACKGROUND: Accurate staging of patients with prostate cancer (PCa) is important for therapeutic decision-making. Relapse after surgery or radiotherapy of curative intent is not uncommon and, in part, represents a failure of staging with current diagnostic imaging techniques to detect disease spread. Prostate-specific membrane antigen (PSMA) positron-emission tomography (PET)/computed tomography (CT) is a new whole-body scanning technique that enables visualization of PCa with high contrast. The hypotheses of this study are that: (i) PSMA-PET/CT has improved diagnostic performance compared with conventional imaging; (ii) PSMA-PET/CT should be used as a first-line diagnostic test for staging; (iii) the improved diagnostic performance of PSMA-PET/CT will result in significant management impact; and (iv) there are economic benefits if PSMA-PET/CT is incorporated into the management algorithm. OBJECTIVES AND METHODS: The proPSMA trial is a prospective, multicentre study in which patients with untreated high-risk PCa will be randomized to gallium-68-PSMA-11 PET/CT or conventional imaging, consisting of CT of the abdomen/pelvis and bone scintigraphy with single-photon emission CT/CT. Patients eligible for inclusion are those with newly diagnosed PCa with select high-risk features, defined as International Society of Urological Pathology grade group ≥3 (primary Gleason grade 4, or any Gleason grade 5), prostate-specific antigen level ≥20 ng/mL or clinical stage ≥T3. Patients with negative, equivocal or oligometastatic disease on first line-imaging will cross over to receive the other imaging arm. The primary objective is to compare the accuracy of PSMA-PET/CT with that of conventional imaging for detecting nodal or distant metastatic disease. Histopathological, imaging and clinical follow-up at 6 months will define the primary endpoint according to a predefined scoring system. Secondary objectives include comparing management impact, the number of equivocal studies, the incremental value of second-line imaging in patients who cross over, the cost of each imaging strategy, radiation exposure, inter-observer agreement and safety of PSMA-PET/CT. Longer-term follow-up will also assess the prognostic value of a negative PSMA-PET/CT. OUTCOME AND SIGNIFICANCE: This trial will provide data to establish whether PSMA-PET/CT should replace conventional imaging in the primary staging of select high-risk localized PCa, or whether it should be used to provide incremental diagnostic information in selected cases.

Audit of radiation dose delivered in time-resolved four-dimensional computed tomography in a radiotherapy department.

INTRODUCTION: To review the dose delivered to patients in time-resolved computed tomography (4D CT) used for radiotherapy treatment planning. METHODS: 4D CT is used at Peter MacCallum Cancer Centre since July 2007 for radiotherapy treatment planning using a Philips Brilliance Wide Bore CT scanner (16 slice, helical 4D CT acquisition). All scans are performed at 140 kVp and reconstructed in 10 datasets for different phases of the breathing cycle. Dose records were analysed retrospectively for 387 patients who underwent 4D CT procedures between 2007 and 2013. RESULTS: A total of 444 4D CT scans were acquired with the majority of them (342) being for lung cancer radiotherapy. Volume CT dose index (CTDIvol) as recorded over this period was fairly constant at approximately 20 mGy for adults. The CTDI for 4D CT for lung cancers of 19.6 ± 9.3 mGy (n = 168, mean ± 1SD) was found to be 63% higher than CTDIs for conventional CT scans for lung patients that were acquired in the same period (CTDIvol 12 ± 4 mGy, sample of n = 25). CTDI and dose length product (DLP) increased with increasing field of view; however, no significant difference between DLPs for different indications (breast, kidney, liver and lung) could be found. Breathing parameters such as breathing rate or pattern did not affect dose. CONCLUSION: 4D CT scans can be acquired for radiotherapy treatment planning with a dose less than twice the one required for conventional CT scanning.