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[68Ga]Ga-P16-093 as a PSMA-Targeted PET Radiopharmaceutical for Detection of Cancer: Initial Evaluation and Comparison with [68Ga]Ga-PSMA-11 in Prostate Cancer Patients Presenting with Biochemical Recurrence.

Abstract

PURPOSE

This study was undertaken to evaluate radiation dosimetry for the prostate-specific membrane antigen targeted [68Ga]Ga-P16-093 radiopharmaceutical, and to initially assess agent performance in positron emission tomography (PET) detection of the site of disease in prostate cancer patients presenting with biochemical recurrence.

PROCEDURES

Under IND 133,222 and an IRB-approved research protocol, we evaluated the biodistribution and pharmacokinetics of [68Ga]Ga-P16-093 with serial PET imaging following intravenous administration to ten prostate cancer patients with biochemical recurrence. The recruited subjects were all patients in whom a recent [68Ga]Ga-PSMA-11 PET/X-ray computed tomography (CT) exam had been independently performed under IND 131,806 to assist in decision-making with regard to their clinical care. Voided urine was collected from each subject at ~ 60 min and ~ 140 min post-[68Ga]Ga-P16-093 injection and assayed for Ga-68 content. Following image segmentation to extract tissue time-activity curves and corresponding cumulated activity values, radiation dosimetry estimates were calculated using IDAC Dose 2.1. The prior [68Ga]Ga-PSMA-11 PET/CT exam (whole-body PET imaging at 60 min post-injection, performed with contrast-enhanced diagnostic CT) served as a reference scan for comparison to the [68Ga]Ga-P16-093 findings.

RESULTS

[68Ga]Ga-P16-093 PET images at 60 min post-injection provided diagnostic information that appeared equivalent to the subject's prior [68Ga]Ga-PSMA-11 scan. With both radiopharmaceuticals, sites of tumor recurrence were found in eight of the ten patients, identifying 16 lesions. The site of recurrence was not detected with either agent for the other two subjects. Bladder activity was consistently lower with [68Ga]Ga-P16-093 than [68Ga]Ga-PSMA-11. The kidneys, spleen, salivary glands, and liver receive the highest radiation exposure from [68Ga]Ga-P16-093, with estimated doses of 1.7 × 10-1, 6.7 × 10-2, 6.5 × 10-2, and 5.6 × 10-2 mGy/MBq, respectively. The corresponding effective dose from [68Ga]Ga-P16-093 is 2.3 × 10-2 mSv/MBq.

CONCLUSIONS

[68Ga]Ga-P16-093 provided diagnostic information that appeared equivalent to [68Ga]Ga-PSMA-11 in this limited series of ten prostate cancer patients presenting with biochemical recurrence, with the kidneys found to be the critical organ. Diminished tracer appearance in the urine represents a potential advantage of [68Ga]Ga-P16-093 over [68Ga]Ga-PSMA-11 for detection of lesions in the pelvis.

Authors+Show Affiliations

Department of Radiology and Imaging Sciences, Indiana University School of Medicine, 950 West Walnut Street; R2-E124, Indianapolis, IN, 46202, USA. magreen@iu.edu.Department of Radiology and Imaging Sciences, Indiana University School of Medicine, 950 West Walnut Street; R2-E124, Indianapolis, IN, 46202, USA.Department of Urology, Indiana University School of Medicine, Indianapolis, IN, USA.Department of Radiology and Imaging Sciences, Indiana University School of Medicine, 950 West Walnut Street; R2-E124, Indianapolis, IN, 46202, USA.Department of Radiology and Imaging Sciences, Indiana University School of Medicine, 950 West Walnut Street; R2-E124, Indianapolis, IN, 46202, USA.Department of Radiology and Imaging Sciences, Indiana University School of Medicine, 950 West Walnut Street; R2-E124, Indianapolis, IN, 46202, USA.Department of Radiology and Imaging Sciences, Indiana University School of Medicine, 950 West Walnut Street; R2-E124, Indianapolis, IN, 46202, USA.Department of Radiology and Imaging Sciences, Indiana University School of Medicine, 950 West Walnut Street; R2-E124, Indianapolis, IN, 46202, USA.Five Eleven Pharma, Inc., Philadelphia, PA, USA.Five Eleven Pharma, Inc., Philadelphia, PA, USA.Five Eleven Pharma, Inc., Philadelphia, PA, USA.Department of Radiology and Imaging Sciences, Indiana University School of Medicine, 950 West Walnut Street; R2-E124, Indianapolis, IN, 46202, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31429050

Citation

Green, Mark A., et al. "[68Ga]Ga-P16-093 as a PSMA-Targeted PET Radiopharmaceutical for Detection of Cancer: Initial Evaluation and Comparison With [68Ga]Ga-PSMA-11 in Prostate Cancer Patients Presenting With Biochemical Recurrence." Molecular Imaging and Biology, 2019.
Green MA, Hutchins GD, Bahler CD, et al. [68Ga]Ga-P16-093 as a PSMA-Targeted PET Radiopharmaceutical for Detection of Cancer: Initial Evaluation and Comparison with [68Ga]Ga-PSMA-11 in Prostate Cancer Patients Presenting with Biochemical Recurrence. Mol Imaging Biol. 2019.
Green, M. A., Hutchins, G. D., Bahler, C. D., Tann, M., Mathias, C. J., Territo, W., ... Fletcher, J. W. (2019). [68Ga]Ga-P16-093 as a PSMA-Targeted PET Radiopharmaceutical for Detection of Cancer: Initial Evaluation and Comparison with [68Ga]Ga-PSMA-11 in Prostate Cancer Patients Presenting with Biochemical Recurrence. Molecular Imaging and Biology, doi:10.1007/s11307-019-01421-7.
Green MA, et al. [68Ga]Ga-P16-093 as a PSMA-Targeted PET Radiopharmaceutical for Detection of Cancer: Initial Evaluation and Comparison With [68Ga]Ga-PSMA-11 in Prostate Cancer Patients Presenting With Biochemical Recurrence. Mol Imaging Biol. 2019 Aug 19; PubMed PMID: 31429050.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [68Ga]Ga-P16-093 as a PSMA-Targeted PET Radiopharmaceutical for Detection of Cancer: Initial Evaluation and Comparison with [68Ga]Ga-PSMA-11 in Prostate Cancer Patients Presenting with Biochemical Recurrence. AU - Green,Mark A, AU - Hutchins,Gary D, AU - Bahler,Clinton D, AU - Tann,Mark, AU - Mathias,Carla J, AU - Territo,Wendy, AU - Sims,Justin, AU - Polson,Heather, AU - Alexoff,David, AU - Eckelman,William C, AU - Kung,Hank F, AU - Fletcher,James W, Y1 - 2019/08/19/ PY - 2019/8/21/entrez PY - 2019/8/21/pubmed PY - 2019/8/21/medline KW - Biochemical recurrence of prostate cancer KW - Dosimetry KW - PSMA-targeted PET KW - Prostate cancer imaging KW - [68Ga]Ga-P16-093 JF - Molecular imaging and biology JO - Mol Imaging Biol N2 - PURPOSE: This study was undertaken to evaluate radiation dosimetry for the prostate-specific membrane antigen targeted [68Ga]Ga-P16-093 radiopharmaceutical, and to initially assess agent performance in positron emission tomography (PET) detection of the site of disease in prostate cancer patients presenting with biochemical recurrence. PROCEDURES: Under IND 133,222 and an IRB-approved research protocol, we evaluated the biodistribution and pharmacokinetics of [68Ga]Ga-P16-093 with serial PET imaging following intravenous administration to ten prostate cancer patients with biochemical recurrence. The recruited subjects were all patients in whom a recent [68Ga]Ga-PSMA-11 PET/X-ray computed tomography (CT) exam had been independently performed under IND 131,806 to assist in decision-making with regard to their clinical care. Voided urine was collected from each subject at ~ 60 min and ~ 140 min post-[68Ga]Ga-P16-093 injection and assayed for Ga-68 content. Following image segmentation to extract tissue time-activity curves and corresponding cumulated activity values, radiation dosimetry estimates were calculated using IDAC Dose 2.1. The prior [68Ga]Ga-PSMA-11 PET/CT exam (whole-body PET imaging at 60 min post-injection, performed with contrast-enhanced diagnostic CT) served as a reference scan for comparison to the [68Ga]Ga-P16-093 findings. RESULTS: [68Ga]Ga-P16-093 PET images at 60 min post-injection provided diagnostic information that appeared equivalent to the subject's prior [68Ga]Ga-PSMA-11 scan. With both radiopharmaceuticals, sites of tumor recurrence were found in eight of the ten patients, identifying 16 lesions. The site of recurrence was not detected with either agent for the other two subjects. Bladder activity was consistently lower with [68Ga]Ga-P16-093 than [68Ga]Ga-PSMA-11. The kidneys, spleen, salivary glands, and liver receive the highest radiation exposure from [68Ga]Ga-P16-093, with estimated doses of 1.7 × 10-1, 6.7 × 10-2, 6.5 × 10-2, and 5.6 × 10-2 mGy/MBq, respectively. The corresponding effective dose from [68Ga]Ga-P16-093 is 2.3 × 10-2 mSv/MBq. CONCLUSIONS: [68Ga]Ga-P16-093 provided diagnostic information that appeared equivalent to [68Ga]Ga-PSMA-11 in this limited series of ten prostate cancer patients presenting with biochemical recurrence, with the kidneys found to be the critical organ. Diminished tracer appearance in the urine represents a potential advantage of [68Ga]Ga-P16-093 over [68Ga]Ga-PSMA-11 for detection of lesions in the pelvis. SN - 1860-2002 UR - https://www.unboundmedicine.com/medline/citation/31429050/[68Ga]Ga-P16-093_as_a_PSMA-Targeted_PET_Radiopharmaceutical_for_Detection_of_Cancer:_Initial_Evaluation_and_Comparison_with_[68Ga]Ga-PSMA-11_in_Prostate_Cancer_Patients_Presenting_with_Biochemical_Recurrence L2 - https://linkinghub.elsevier.com/retrieve/pii/10.1007/s11307-019-01421-7 DB - PRIME DP - Unbound Medicine ER -