Abstract
Purpose
Prostate-specific membrane antigen (PSMA) is a promising molecular target for imaging of prostate adenocarcinoma. 68Ga-P16-093, a small molecule PSMA ligand, previously showed equivalent diagnostic performance compared to 68Ga-PSMA-11 PET/CT in a pilot study of prostate cancer patients with biochemical recurrence (BCR). We performed a pilot study for further characterization of 68Ga-P16-093 including comparison to conventional imaging.
Procedures
Patients were enrolled into two cohorts. The biodistribution cohort included 8 treated prostate cancer patients without recurrence, who underwent 6 whole body PET/CT scans with urine sampling for dosimetry using OLINDA/EXM. The dynamic cohort included 15 patients with BCR and 2 patients with primary prostate cancer. Two patients with renal cell carcinoma were also enrolled for exploratory use. A dynamic PET/CT was followed by 2 whole body scans for imaging protocol optimization based on bootstrapped replicates. 68Ga-P16-093 PET/CT was compared for diagnostic performance against available 18F-fluciclovine PET/CT, 99mTc-MDP scintigraphy, diagnostic CT, and MRI.
Results
68Ga-P16-093 deposited similar effective dose (0.024 mSv/MBq) and lower urinary bladder dose (0.064 mSv/MBq) compared to 68Ga-PSMA-11. The kidneys were the critical organ (0.290 mSv/MBq). While higher injected activities were preferable, lower injected activities at 74–111 MBq (2–3 mCi) yielded 80% retention in signal-to-noise ratio. The optimal injection-to-scan interval was 60 min, with acceptable delay up to 90 min. 68Ga-P16-093 PET/CT showed superior diagnostic performance over conventional imaging with overall patient-level lesion detection rate of 71%, leading to a change in management in 42% of the patients.
Conclusions
Based on its favorable imaging characteristics and diagnostic performance in prostate cancer, 68Ga-P16-093 PET/CT merits further investigation in larger clinical studies.
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Funding
Funding support for the work was received from Five Eleven Pharma. Five Eleven Pharma’s development and synthesis of 68Ga-P16-093 were supported by NIH/NCI SBIR grants 1R44CA233140-01 and 1R43CA217425-01.
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The University of Pennsylvania Institutional Review Board approved the study. All the procedures performed involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all the individual participants included in the study.
Conflict of Interest
David Alexoff: CEO of Five Eleven Pharma Inc.
Hank F. Kung: Founder and Chairman of the board at Five Eleven Pharma Inc.
Daniel A. Pryma: Research Consultant, Five Eleven Pharma Inc.; Research Consultant, Progenics Pharmaceuticals Inc.; Research Consultant, Actinium Pharmaceuticals Inc.; Research Consultant, Ipsen; Research Grant, Siemens AG; Research Grant, Five Eleven Pharma Inc.; Research Grant, Progenics Pharmaceuticals Inc.; Clinical Trial Funding, Nordic Nanovector ASA.
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Lee, H., Scheuermann, J.S., Young, A.J. et al. Preliminary Evaluation of 68Ga-P16-093, a PET Radiotracer Targeting Prostate-Specific Membrane Antigen in Prostate Cancer. Mol Imaging Biol 24, 710–720 (2022). https://doi.org/10.1007/s11307-022-01720-6
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DOI: https://doi.org/10.1007/s11307-022-01720-6