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Trial Title:
The Combination of PSMA-PET/MR and p2PSA in Early Diagnosis of Prostate Cancer
NCT ID:
NCT05822726
Condition:
Prostate Cancer
PSMA
p2PSA
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Prostate biopsy
Description:
Targeted guided puncture biopsy guided by B-ultrasound will be performed (in addition to
12-needle system biopsy, if PSMA-PET/MRI or mpMRI indicates a positive lesion, puncture
biopsy should be added at the lesion displayed on image, the "12-needle system biopsy+X"
scheme).
Arm group label:
The combination of PSMA-PET/MR and p2PSA
Arm group label:
The combination of mpMRI and p2PSA
Summary:
This is a single center prospective non-randomized controlled study.
The goal of this clinical trial is to figure out whether the combination of PSMA-PET/MR
and PHI could add values to each method alone. The main questions it aims to answer are:
- Compare the diagnostic value of the combination with each alone and set up a
diagnostic model.
- Compare the diagnostic value of PSMA-PET/MR+PHI to mpMRI+PHI.
- Evaluate the diagnostic value the combination of PHI and PSMA-PET/MR in suspected
PCA patients.
Patients will experience mpMRI or PSMA-PET/MR and their blood samples will be used to
test PSA and p2PSA. Prostate biopsy will be the golden standard.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Preoperative clinical judgment of suspected early prostate cancer (according to NCCN
guidelines): meet PSA ≤ 20ng/ml and clinical stage10 ng/ml；
④ PSA 4~10ng/ml, f/t PSA suspicious or PSAD value suspicious;
2. Aged between 18 and 85 years;
3. Generally in good health, able to tolerate and cooperate with research
interventions, such as prostate biopsy and radical prostatectomy Etc;
4. Provide a signed and dated informed consent form;
5. Commit to complying with research procedures and cooperate in the implementation of
the entire process of research.
Exclusion Criteria:
1. Preoperative clinical characteristics of suspected high-risk prostate cancer
(according to NCCN guidelines): meet PSA>20 ng/ml or clinical stage ≥ T3;
2. Have received any treatment (endocrine therapy, radiotherapy, chemotherapy, prostate
resection, etc.)
3. Have had prostatitis (infectious or non infectious) 3 months before the examination
4. Taking 5a reductase inhibitors
5. Previously diagnosed with prostate cancer
6. In the acute infection period and fever period;
7. Have a hypertensive crisis;
8. In the period of decompensation due to cardiac insufficiency;
9. Diseases with a tendency to severe bleeding;
10. In diabetes, blood sugar is unstable;
11. Have severe internal and external hemorrhoids, perianal or rectal lesions;
12. Combined with other systemic malignant tumors;
13. Implantation of functional electronic devices and various stimulators such as
cardiac pacemakers, cochlear implants, and cardiac stents in vivo, with implants
made of ferromagnetic materials (such as iron, cobalt, nickel, etc.);
14. A perfusion device implanted in the body, such as insulin or other perfusion pumps;
15. Have a history of surgery within the past 3 months, especially organ
transplantation, heart and kidney surgery;
16. People with claustrophobia.
Gender:
Male
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Danfeng Xu
Phone:
(021)64370045
Phone ext:
666062
Email:
xdf12036@rjh.com.cn
Contact backup:
Last name:
Jiacheng Liu
Phone:
+8613501607303
Email:
echohyl1004@gmail.com
Start date:
October 1, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05822726
