68Ga-P16-093 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Primary Prostate Cancer Patients

NCT05324332 · tracked via the Priya Life Science China tracker

Sponsor

Peking Union Medical College Hospital

Phase

Not applicable

Started

2022-04-15

Last updated

2025-09-22

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

68Ga-P16-09368Ga-PSMA-11

68Ga-P16-093: Intravenous injection of 68Ga-P16-093 with the dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of prostate cancer by PET/CT.

68Ga-PSMA-11: Intravenous injection of 68Ga-PSMA-11 with the dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg. Tracer doses of 68Ga-PSMA-11 will be used to image lesions of prostate cancer by PET/CT.

Study summary

Prostate-specific membrane antigen (PSMA)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the most widely studied 68Ga-PSMA-11. This pilot study was evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-11 in the same group of primary prostate cancer patients.

Eligibility

Sex

MALE

Min age

18 Years

Max age

90 Years

Healthy volunteers

Inclusion Criteria: * histologically confirmed untreated primary prostate cancer patients; * 68Ga-PSMA-11 and 68Ga-P16-093 PET/CT within a week; * signed written consent. Exclusion Criteria: * known allergy against PSMA; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Primary outcome measure(s)

Tumor detection rate — through study completion, an average of 1 year
comparing the number of tumor detected by 68Ga-P16-093 and 68Ga-PSMA-11 PET/CT

Trial sites (1)

Facility	City	Region	Status
Peking Union Medical College Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05324332 on ClinicalTrials.gov ↗ ← All trials in China