NCT05324332

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 22, 2025

Status Verified

June 1, 2025

Enrollment Period

2.7 years

First QC Date

April 3, 2022

Last Update Submit

September 17, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor detection rate

    comparing the number of tumor detected by 68Ga-P16-093 and 68Ga-PSMA-11 PET/CT

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • standardized uptake value (SUV) of tumor

    through study completion, an average of 1 year

Other Outcomes (1)

  • PSMA expression and SUV

    through study completion, an average of 1 year

Study Arms (1)

68Ga-P16-093 and 68Ga-PSMA-11 PET/ CT scan

EXPERIMENTAL

Patients of Prostate cancer PET/CT imaging: In two consecutive days, each patient underwent whole-body PET/CT scan after intravenous administration of 68Ga-P16-093 and 68Ga-PSMA-11, respectively.

Drug: 68Ga-P16-093Drug: 68Ga-PSMA-11

Interventions

68Ga-P16-093DRUG

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.

Also known as: 68Ga-P16-093 injection
68Ga-P16-093 and 68Ga-PSMA-11 PET/ CT scan
68Ga-PSMA-11DRUG

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.

Also known as: 68Ga-PSMA-11 injection
68Ga-P16-093 and 68Ga-PSMA-11 PET/ CT scan

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed untreated primary prostate cancer patients;
  • Ga-PSMA-11 and 68Ga-P16-093 PET/CT within a week;
  • signed written consent.

You may not qualify if:

  • known allergy against PSMA;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (2)

  • Wang J, Li L, Chen J, Wang R, Xiang J, Peng X, Wang Y, Luo Y, Zhu L, Kung HF, Zhou Z, Xiao Y, Zhu Z. [68Ga]Ga-P16-093 PET/CT in newly diagnosed prostate cancer: Histopathological validation and comparison with [68Ga]Ga-PSMA-11. Eur J Nucl Med Mol Imaging. 2025 Dec 10. doi: 10.1007/s00259-025-07687-0. Online ahead of print.

    PMID: 41366119DERIVED

  • Wang G, Li L, Zhu M, Zang J, Wang J, Wang R, Yan W, Zhu L, Kung HF, Zhu Z. A prospective head-to-head comparison of [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11 PET/CT in patients with primary prostate cancer. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):3126-3136. doi: 10.1007/s00259-023-06283-4. Epub 2023 May 26.

    PMID: 37233785DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Zhaohui Zhu, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

86-1361109375213611093752@163.com

Guochang Wang, MD

CONTACT

86-18516822732guochang1007@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2022

First Posted

April 12, 2022

Study Start

April 15, 2022

Primary Completion

January 1, 2025

Study Completion

December 31, 2025

Last Updated

September 22, 2025

Record last verified: 2025-06

Locations

CN(1)