A feasibility study on Cerenkov Luminescence Imaging during prostate cancer surgery using Gallium-68 PSMA

Prostate cancer is the second most common cancer in the world and is still the leading cancer among men in the Netherlands with over 10,000 men diagnosed each year. Surgery remains one of the primary treatment options for the disease, yet it is frequently unsuccessful with cancer left behind in a substantial number of men (11-38%). The incomplete removal of cancer during prostate cancer surgery is associated with increased likelihood of disease recurrence and poor patient outcomes. Also, these patients may undergo debilitating adjuvant therapies following surgery that have a marked impact on the patient’s quality of life. Complete surgical excision is challenging, as the surgeon is unable to distinguish between cancerous and non-cancerous tissue during surgery. There is therefore an urgent medical need for surgeons to be able to visualize cancer during an operation to ensure that all of the cancer is completely removed. In this study the feasibility of Gallium-68-Prostate Specific Membrane Antigen (68Ga-PSMA) Cerenkov Luminescence Imaging (CLI) will be investigated as a technique for intraoperative analysis of prostate surgical specimens. This molecular optical technology involves imaging of Cerenkov photons, emitted from radiopharmaceuticals concentrated in cancerous tissue, using an intraoperative CLI system called LightPath®. The primary objective is to assess the feasibility of intra-operative analysis of prostate surgical specimens using 68Ga-PSMA CLI.
Study design: This study is a single-centre, prospective clinical feasibility study.
Study population: This study will include 30 high risk primary prostate cancer patients who are planned to undergo radical prostatectomy.
Intervention (if applicable): Intravenous 68Ga-PSMA injection and ex vivo CLI imaging of excised prostate specimen.
Main study parameters/endpoints: The objective of this study is to assess the feasibility of 68Ga-PSMA CLI for intra-operative analysis of prostate surgical specimens.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The subjects included in this study will receive a certain radiation exposure from the radiotracer 68Ga-PSMA that will be administered in this study. The expected radiation dose will approximately be 2 millisievert (mSV), which fall within acceptable limits.

In this study the feasibility of the CLI will be tested to detect positive surgical margins during surgery. This will be compared to standard histopathology. When there is a good correlation between this detection, this intra-operative margin assessment can guide the surgeon, and may help making the decision to operate nerve sparing or not. By providing information where the tumour is located relative to the neural-vascular bundles.

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Intravenous 68Ga-PSMA injection and ex vivo CLI imaging of excised prostate specimen.