[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.

SUBMITTER: Green MA 

PROVIDER: S-EPMC7028523 | biostudies-literature |

REPOSITORIES: biostudies-literature