68Ga-PSMA PET in the Prostate Cancer

Not Applicable

Recruiting

• Conditions: Metastases; Prostatic Neoplasms; PSMA-PET

• Registration Number: NCT04967001
• Lead Sponsor: Xijing Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-11
• Study First Posted: 2021-07-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PSMA PET/CT	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.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shannxi, China