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NCT04967001 Clinical Trial

68Ga-PSMA PET in the Prostate Cancer

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04967001
Other study ID # KY20212032-F-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2024

Study information
Verified date January 2024
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PSMA PET
68Ga-PSMA PET

Locations
Country Name City State
China Xijing Hospital Xi'an Shannxi

Sponsors (1)
Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PSMA PET/CT 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
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