68Ga-PSMA PET in the Prostate Cancer
Efficacy of 68Ga PSMA PET in the Diagnosis of Lymph Node Metastasis in Patients With Prostate Cancer: a Single Center Prospective Randomized Controlled Trial
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 11, 2021
CompletedFirst Posted
Study publicly available on registry
July 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 25, 2024
January 1, 2024
3 years
July 11, 2021
January 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
PSMAPET-MRI
EXPERIMENTALMRI-PSMAPET
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- High risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended PLND
- ISUP Gleason grade group ≥ 4
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shannxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Director, Department of Urology
Study Record Dates
First Submitted
July 11, 2021
First Posted
July 19, 2021
Study Start
June 1, 2021
Primary Completion
June 1, 2024
Study Completion
December 31, 2024
Last Updated
January 25, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share