68Ga-PSMA PET in the Prostate Cancer

January 23, 2024 updated by: Qin Weijun, Xijing Hospital

Efficacy of 68Ga PSMA PET in the Diagnosis of Lymph Node Metastasis in Patients With Prostate Cancer: a Single Center Prospective Randomized Controlled Trial

Efficacy of 68Ga PSMA PET / CT in the diagnosis of lymph node metastasis in patients with prostate cancer: a single center prospective randomized controlled trial.

To identify and compare the diagnostic efficacy of 68Ga-PSMA PET/CT and mpMRI for lymph nodes in patients with newly diagnosed prostate cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shannxi
      • Xi'an, Shannxi, China, 710032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND
  • ISUP Gleason grade group ≥ 4

Exclusion Criteria:

  • Prior history of any other cancer in the last 5 years excluding basal cell carcinoma Proven metastases in bones or other distant metastases
  • General contra-indications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia)
  • Serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives
  • Metal implants in the pelvic region which will deteriorate PET/MR/CT image quality.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSMAPET-MRI
Diagnostic test: PSMA PET
68Ga-PSMA PET
Experimental: MRI-PSMAPET
Diagnostic test: PSMA PET
68Ga-PSMA PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PSMA PET/CT
Time Frame: 2 years
To compare the diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PET/CT to that of the current standard multiparametric MRI, using histopathology as the gold standard.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 11, 2021

First Submitted That Met QC Criteria

July 11, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20212032-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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