68Ga-PSMA PET in the Prostate Cancer

Xijing Hospital300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

300

Conditions

Prostatic Neoplasms Metastases PSMA-PET

Interventions

PSMA PETDIAGNOSTIC_TEST

68Ga-PSMA PET

Eligibility

Sex: MALEMin age: 40 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Xijing Hospital

Xi'an, Shannxi, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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