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The Combination of PSMA-PET/MR and p2PSA in Early Diagnosis of Prostate Cancer

Primary Purpose

Prostate Cancer, PSMA, p2PSA

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prostate biopsy
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Preoperative clinical judgment of suspected early prostate cancer (according to NCCN guidelines): meet PSA ≤ 20ng/ml and clinical stage<T3, while meeting one of the following criteria: ① Digital rectal examination revealed suspicious nodules of the prostate; ② Transrectal prostate ultrasound or MRI found suspicious lesions; ③ PSA>10 ng/ml; ④ PSA 4~10ng/ml, f/t PSA suspicious or PSAD value suspicious; Aged between 18 and 85 years; Generally in good health, able to tolerate and cooperate with research interventions, such as prostate biopsy and radical prostatectomy Etc; Provide a signed and dated informed consent form; Commit to complying with research procedures and cooperate in the implementation of the entire process of research. Exclusion Criteria: Preoperative clinical characteristics of suspected high-risk prostate cancer (according to NCCN guidelines): meet PSA>20 ng/ml or clinical stage ≥ T3; Have received any treatment (endocrine therapy, radiotherapy, chemotherapy, prostate resection, etc.) Have had prostatitis (infectious or non infectious) 3 months before the examination Taking 5a reductase inhibitors Previously diagnosed with prostate cancer In the acute infection period and fever period; Have a hypertensive crisis; In the period of decompensation due to cardiac insufficiency; Diseases with a tendency to severe bleeding; In diabetes, blood sugar is unstable; Have severe internal and external hemorrhoids, perianal or rectal lesions; Combined with other systemic malignant tumors; 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.); A perfusion device implanted in the body, such as insulin or other perfusion pumps; Have a history of surgery within the past 3 months, especially organ transplantation, heart and kidney surgery; People with claustrophobia.

Sites / Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The combination of PSMA-PET/MR and p2PSA

The combination of mpMRI and p2PSA

Arm Description

Outcomes

Primary Outcome Measures

biospy outcome
Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between both methods and set up a diagnostic model.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2023
Last Updated
April 9, 2023
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05822726
Brief Title
The Combination of PSMA-PET/MR and p2PSA in Early Diagnosis of Prostate Cancer
Official Title
The Combination of PSMA-PET/MRI and p2PSA in Early Diagnosis of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, PSMA, p2PSA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The combination of PSMA-PET/MR and p2PSA
Arm Type
Experimental
Arm Title
The combination of mpMRI and p2PSA
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Prostate biopsy
Intervention 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).
Primary Outcome Measure Information:
Title
biospy outcome
Description
Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between both methods and set up a diagnostic model.
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preoperative clinical judgment of suspected early prostate cancer (according to NCCN guidelines): meet PSA ≤ 20ng/ml and clinical stage<T3, while meeting one of the following criteria: ① Digital rectal examination revealed suspicious nodules of the prostate; ② Transrectal prostate ultrasound or MRI found suspicious lesions; ③ PSA>10 ng/ml; ④ PSA 4~10ng/ml, f/t PSA suspicious or PSAD value suspicious; Aged between 18 and 85 years; Generally in good health, able to tolerate and cooperate with research interventions, such as prostate biopsy and radical prostatectomy Etc; Provide a signed and dated informed consent form; Commit to complying with research procedures and cooperate in the implementation of the entire process of research. Exclusion Criteria: Preoperative clinical characteristics of suspected high-risk prostate cancer (according to NCCN guidelines): meet PSA>20 ng/ml or clinical stage ≥ T3; Have received any treatment (endocrine therapy, radiotherapy, chemotherapy, prostate resection, etc.) Have had prostatitis (infectious or non infectious) 3 months before the examination Taking 5a reductase inhibitors Previously diagnosed with prostate cancer In the acute infection period and fever period; Have a hypertensive crisis; In the period of decompensation due to cardiac insufficiency; Diseases with a tendency to severe bleeding; In diabetes, blood sugar is unstable; Have severe internal and external hemorrhoids, perianal or rectal lesions; Combined with other systemic malignant tumors; 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.); A perfusion device implanted in the body, such as insulin or other perfusion pumps; Have a history of surgery within the past 3 months, especially organ transplantation, heart and kidney surgery; People with claustrophobia.
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danfeng Xu
Phone
(021)64370045
Ext
666062
Email
xdf12036@rjh.com.cn
First Name & Middle Initial & Last Name & Degree
Jiacheng Liu
Phone
+8613501607303
Email
echohyl1004@gmail.com

12. IPD Sharing Statement

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The Combination of PSMA-PET/MR and p2PSA in Early Diagnosis of Prostate Cancer

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