NCT04796467

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 widely studied 68Ga-PSMA-617. This pilot study was prospectively designed to evaluate the early dynamic distribution of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-617 in the same group of prostate cancer patients.

Trial Health

43
At Risk

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 P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

February 23, 2021

Last Update Submit

August 4, 2022

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Metabolic parameters

    the early dynamic distribution (SUVmax in tumor lesions and SUVmean in normal organs at different time points) of 68Ga-P16-093 in comparison with 68Ga-PSMA-617 in the same group of prostate cancer patients.

    through study completion, an average of 1 year]

Secondary Outcomes (2)

  • detection capability of tumor

    through study completion, an average of 1 year

  • SUVmax 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-PSMA617 and 68Ga-P16-093 PET/CT scan

EXPERIMENTAL

Patients of Prostate cancer PET/CT imaging: In two consecutive days each patient underwent a PET/CT scan after intravenous administration of 68Ga-PSMA617 and 68Ga-P16-093, respectively.

Drug: 68Ga-PSMA-617Drug: 68Ga-P16-093

Interventions

68Ga-PSMA-617DRUG

Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT.

Also known as: 68Ga-PSMA-617 injection
68Ga-PSMA617 and 68Ga-P16-093 PET/CT scan
68Ga-P16-093DRUG

Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-P16-093. 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-PSMA617 and 68Ga-P16-093 PET/CT scan

Eligibility Criteria

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

You may qualify if:

  • confirmed treated or untreated prostate cancer patients;
  • Ga-PSMA617 and 68Ga-P16-093 PET/CT within two consecutive days;
  • 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 G, Li L, Zang J, Hong H, Zhu L, Kung HF, Zhu Z. Head-to-Head Comparison of 68 Ga-P16-093 and 68 Ga-PSMA-617 PET/CT in Patients With Primary Prostate Cancer : A Pilot Study. Clin Nucl Med. 2023 Apr 1;48(4):289-295. doi: 10.1097/RLU.0000000000004566. Epub 2023 Jan 20.

    PMID: 36727866DERIVED

  • Wang G, Hong H, Zang J, Liu Q, Jiang Y, Fan X, Zhu Z, Zhu L, Kung HF. Head-to-head comparison of [68 Ga]Ga-P16-093 and [68 Ga]Ga-PSMA-617 in dynamic PET/CT evaluation of the same group of recurrent prostate cancer patients. Eur J Nucl Med Mol Imaging. 2022 Feb;49(3):1052-1062. doi: 10.1007/s00259-021-05539-1. Epub 2021 Sep 23.

    PMID: 34557930DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

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
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 12, 2021

Study Start

October 1, 2020

Primary Completion

August 1, 2021

Study Completion

October 1, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

CN(1)