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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; PSMA; p2PSA
• Intervention / Treatment: Diagnostic test: Prostate biopsy

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Ruijin Hospital, Shanghai JiaoTong University School of Medicine
      • Contact: Jiacheng Liu; Phone Number: +8613501607303; Email: echohyl1004@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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;

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The combination of PSMA-PET/MR and p2PSA	Diagnostic test: Prostate biopsy; 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).
Active Comparator: The combination of mpMRI and p2PSA	Diagnostic test: Prostate biopsy; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biospy outcome	Compare the diagnostic value (including sensitivity, specificity, NPV and PPV) between both methods and set up a diagnostic model.	12 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 9, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CPMP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No