Back to results68Ga-PSMA PET in the Prostate Cancer
Primary Purpose
Prostatic Neoplasms, Metastases, PSMA-PET
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PSMA PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasms
Eligibility Criteria
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 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.
Sites / Locations
- Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PSMAPET-MRI
MRI-PSMAPET
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04967001
Brief Title
68Ga-PSMA PET in the Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Metastases, PSMA-PET
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PSMAPET-MRI
Arm Type
Experimental
Arm Title
MRI-PSMAPET
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
PSMA PET
Intervention Description
68Ga-PSMA PET
Primary Outcome Measure Information:
Title
Diagnostic accuracy of PSMA PET and combined PSMA PET/MRI or PSMA PET/CT
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shannxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Jia
Phone
+86 029 8477 1794
Email
jiayanyan-2004@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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68Ga-PSMA PET in the Prostate Cancer
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