The Combination of PSMA-PET/MR and p2PSA in Early Diagnosis of Prostate Cancer
Prostate Cancer, PSMA, p2PSA
About this trial
This is an interventional diagnostic trial for Prostate Cancer
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.
Sites / Locations
- Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
The combination of PSMA-PET/MR and p2PSA
The combination of mpMRI and p2PSA