Prostate Cancer
Conditions
Interventions
Exposure group (PSMA PET/CT):None
Control group (MRI):None
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male, aged 45–85 years. 2. Clinical suspicion of prostate cancer (must meet at least one of the following criteria): (1) Serum PSA > 4 ng/mL; or fPSA/PSA 0.16 ng/mL^2; (2) Suspicious findings on digital rectal examination (DRE); (3) Prior imaging (ultrasound, CT, etc.) suggestive of a prostate mass or induration. 3. Planned to undergo initial imaging stratification at this center, with imaging protocol aligned to study group assignment: (1) Exposure group: Presence of absolute or relative contraindications to MRI, undergoing PSMA PET/CT only; (2) Control group: Able to tolerate MRI, planned to undergo standard 3.0 T multiparametric MRI (mpMRI). 4. Biopsy and subsequent follow-up can be completed at this institution, and participants are expected to comply with >=6 months of follow-up. 5. Written informed consent has been obtained; participants fully understand the study objectives and consent to the use of their imaging, pathological, and clinical data for research purposes.
Exclusion criteria
Exclusion criteria: 1. History of prior diagnosis or treatment for prostate cancer (including surgery, radiotherapy, androgen deprivation therapy (ADT), ablation, or radiopharmaceutical therapy, etc.). 2. Systemic or targeted prostate biopsy performed within the past 6 months. 3. Imaging has confirmed distant metastasis (M1) or extensive regional lymph node metastasis (cN2 or higher). 4. Contraindications to or inability to complete the study-specified imaging: (1) Severe allergy to components of the 68Ga/¹8F-PSMA tracer; (2) eGFR 200 kg, or inability to lie supine for >=30 minutes. 5. Coexisting severe cardiopulmonary, hematologic, or psychiatric conditions that, in the investigator’s judgment, may compromise imaging safety or follow-up compliance. 6. Participation in another interventional clinical trial within the past 3 months that may interfere with the assessment of the primary outcome. 7. Inability to provide valid identification documents, or refusal to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of clinical significance prostate cancer; | — |
Countries
China
Contacts
Public ContactHuang Yuhua
The First Affiliated Hospital of Soochow University
Outcome results
None listed