NCT07209878

Brief Summary

68Ga-PSMA-11 is a widely used radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-PSMA-11 PET imaging (PET/CT or PET/MRI) in patients with newly diagnosed, treatment-naive prostate cancer, and performed a head-to-head comparison with multi-parameter magnetic resonance imaging (mpMRI).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
2mo left

Started Jan 2020

Longer than P75 for phase_2

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 Progress98%
Jan 2020Jun 2026

Study Start

First participant enrolled

January 10, 2020

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

6 years

First QC Date

September 30, 2025

Last Update Submit

September 30, 2025

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

PSMAProstate cancerPET imagingmpMRI

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of 68Ga-PSMA-11 Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants

    Using histopathology from radical prostatectomy as the reference standard, validate the true positive detection rate of PET for prostate lesions. Two experienced nuclear medicine physicians, blinded to all other imaging and clinical history of the patients, independently assessed the PET images. Any disagreements were resolved by consensus.

    Within 28 days of imaging, radical prostatectomy will occur.

  • Specificity of 68Ga-PSMA-11 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants

    Using histopathology from radical prostatectomy as the reference standard, validate the true negative detection rate of PET for prostate lesions. Two experienced nuclear medicine physicians, blinded to all other imaging and clinical history of the patients, independently assessed the PET images. Any disagreements were resolved by consensus.

    Within 28 days of imaging, radical prostatectomy will occur.

Secondary Outcomes (1)

  • Comparison of Detection Rates for Intraprostatic Tumors Between 68Ga-PSMA-11 PET Imaging and mpMRI

    Within 1-2 hours of 68Ga-PSMA-11 dosing, a whole body PET scan will be taken

Study Arms (1)

68Ga-PSMA-11 PET/CT

EXPERIMENTAL

Intravenous injection of 68Ga-PSMA-11 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT or PET/MRI acquisition according to standard methods

Drug: 68Ga-PSMA-11

Interventions

68Ga-PSMA-11DRUG

Intravenous injection of 68Ga-PSMA-11 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT or PET/MRI acquisition according to standard methods.

68Ga-PSMA-11 PET/CT

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy-confirmed adenocarcinoma of the prostate.
  • No anti-tumor treatment received prior to the PET imaging.
  • Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
  • Radical prostatectomy scheduled within 28 days after PET imaging

You may not qualify if:

  • Patients with other malignant tumors
  • Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.

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

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

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

Study Officials

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

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 7, 2025

Study Start

January 10, 2020

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

October 7, 2025

Record last verified: 2025-09

Locations

CN(1)