Metastases, Prostatic Neoplasms, PSMA-PET
Conditions
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.
Interventions
DIAGNOSTIC_TESTPSMA PET
68Ga-PSMA PET
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed