Abstract
This study was prospectively designed to evaluate the early dynamic organ distribution and tumor detection capability of [68Ga]Ga-P16-093, which was compared with [68Ga]Ga-PSMA-617 in the same group of recurrent prostate cancer patients. Twenty patients with recurrent prostate cancer were enrolled. In 2 consecutive days, each patient underwent a 60-min dynamic PET/CT scan after intravenous administration of 148-185MBq (4-5mCi) [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-617, respectively. Following a low-dose CT scan, serial dynamic PET scans were performed from head to proximal thigh at 9 time points (30s/bed at 4, 7, 10, 13, and 16min; 1min/bed at 20, 30, and 45min; and 2min/bed at 60min). Standardized uptake values were measured for semi-quantitative comparison. [68Ga]Ga-P16-093 PET/CT revealed a significantly higher tumor uptake at 4min (SUVmax 7.88 ± 5.26 vs. 6.01 ± 3.88, P < 0.001), less blood pool retention at 4min (SUVmean 5.12 ± 1.16 vs. 6.14 ± 0.98, P < 0.001), and lower bladder accumulation at 60min (SUVmean 31.33 ± 27.47 vs. 48.74 ± 34.01, P = 0.042) than [68Ga]Ga-PSMA-617 scan. Significantly higher [68Ga]Ga-P16-093 uptakes were also observed in the parotid gland, liver, spleen, and kidney. Besides, [68Ga]Ga-P16-093 exhibited a better detectability of tumor than [68Ga]Ga-PSMA-617 (366 vs. 321, P = 0.009). [68Ga]Ga-P16-093 showed advantages over [68Ga]Ga-PSMA-617 with higher tumor uptakes, tumor-to-blood pool ratio and detection capability, less blood pool, and bladder accumulation in recurrent prostate cancer patients. [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients (NCT04796467, Registered 12 March 2021, retrospectively registered) URL of registry: https://clinicaltrials.gov/ct2/show/NCT04796467.
Highlights
Prostate cancer (PCa) is one of the most common male malignancy and a leading cause of death [1]
A total of 20 patients with recurrent PCa after therapies were enrolled into the study from October 2020 to May 2021, including 6 cases of biochemical recurrence (BCR) and 14 cases of metastatic castration-resistant prostate cancer (mCRPC), the average age of them was 67.8 ± 6.6 years, with a mean Gleason score of 8.5 ± 1.1 and a mean prostate specific antigen (PSA) level of 36.5 ± 42.0 ng/ml
There were no adverse events and clinically evident pharmacological reactions associated with the injection of [68Ga]Ga-P16-093 and [68Ga]Ga-Prostate specific membrane antigen (PSMA)-617
Summary
Prostate cancer (PCa) is one of the most common male malignancy and a leading cause of death [1]. Blood prostate specific antigen (PSA) test, digital rectal examination (DRE), and transrectal ultrasound (TRUS) are classic methods to monitor PCa, which are the most common approaches for clinical screening of PCa by far. Abnormal DRE is an indication for biopsy, but as an independent variable, it’s reported that PSA value is a better predictor of PCa than either DRE or TRUS [2]. All the above methods have unsurmountable limitations in tumor exact localization, staging of disease, distinguishing between chronic prostatitis and PCa and so on. MpMRI exhibited some drawbacks as its specificity for high-grade PCa is only moderate (37%) and limited tumor staging, which are critical for clinical decision-making [4, 5]
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