NCT07363382

Brief Summary

The gastrin-releasing peptide receptor (GRPR) is highly expressed in prostate cancer (77%-100%). Numerous studies have confirmed that GRPR PET imaging has emerged as a significant molecular imaging modality in prostate cancer, particularly serving as a complementary tool to PSMA PET for addressing cases with negative or insufficient PSMA expression. It demonstrates substantial value in initial staging (especially in intermediate- and high-risk patients), detecting sites of biochemical recurrence, assessing metastatic lesions (notably in mCRPC), and guiding treatment decisions. 68Ga-G21 and 68Ga-G23 are two novel molecular probes targeting GRPR. This study aims to evaluate their biodistribution and diagnostic performance in prostate cancer and compare them with 68Ga-PSMA-11 PET imaging.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
20mo left

Started Dec 2025

Typical duration for phase_1

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

Study Progress19%
Dec 2025Dec 2027

Study Start

First participant enrolled

December 20, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

Prostate Cancer (Adenocarcinoma)

Outcome Measures

Primary Outcomes (2)

  • Number of participants with Imaging Emergent Adverse Events

    The distribution of adverse events (AE) will be done via the analysis of frequencies for imaging emergent Adverse Event, through the monitoring of relevant clinical and laboratory safety parameters.

    From enrollment till 7 days safety follow-up

  • Dosimetry data

    Calculate the absorbed dose of 68Ga-G21 and 68Ga-G23 in normal organs.

    through study completion, an average of 3 months

Secondary Outcomes (1)

  • Diagnostic value

    through study completion, an average of 3 months

Study Arms (2)

68Ga-G21 PET imaging

EXPERIMENTAL

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-G21. Tracer of 68Ga-G21 will be used to image lesions of prostate cancer by PET imaging.

Drug: 68Ga-G21

68Ga-G23 PET imaging

EXPERIMENTAL

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-G23. Tracer of 68Ga-G23 will be used to image lesions of prostate cancer by PET imaging.

Drug: 68Ga-G23

Interventions

68Ga-G21DRUG

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-G21. Tracer of 68Ga-G21 will be used to image lesions of prostate cancer by PET imaging.

68Ga-G21 PET imaging
68Ga-G23DRUG

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-G23. Tracer of 68Ga-G23 will be used to image lesions of prostate cancer by PET imaging.

68Ga-G23 PET imaging

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;
  • 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)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Weibing Miao, MD

    First Affiliated Hospital of Fujian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weibing Miao, MD

CONTACT

86-0591-87981618miaoweibing@126.com

Guochang Wang, MD

CONTACT

86-0591-87981619guochang1007@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 23, 2026

Study Start

December 20, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

CN(1)