多参数磁共振成像（ mpMRI ）是前列腺癌诊断和局灶性治疗规划的标准成像方式。然而， 10-20%的临床显著前列腺癌（ csPCa ）在mpMRI上不可见（ PI-RADS 1-2 ）。
适应症：Prostate Cancer
入组条件
纳入标准
- Men aged ≥50 years
- Life expectancy \>10 years
- Histologically confirmed localized prostate cancer, ISUP Grade Group 2 or 3
- At least one clinically significant cancer focus (≥1 systematic biopsy core with Grade Group 2-3) that is MRI-invisible, defined as:
- \- The corresponding sextant/region on mpMRI (performed within 6 months) shows PI-RADS v2.1 score 1 or 2, or no identifiable lesion that could account for the positive biopsy
- Total of 1-2 discrete cancer foci (MRI-visible + PET-detected MRI-invisible) on study entry, with each MRI-visible focus having maximum diameter ≤15 mm on mpMRI
- Organ-confined disease on mpMRI and no evidence of seminal vesicle invasion or lymph node/distant metastasis
- Serum PSA \<20 ng/mL
- Able to provide informed consent
排除标准
- Previous treatment for prostate cancer (radiotherapy, surgery, focal therapy, androgen deprivation)
- Prior pelvic radiotherapy for any cause
- Contraindication to MRI or gadolinium contrast
- Contraindication to PSMA PET-CT (e.g. severe claustrophobia, inability to lie flat)
- Contraindication to general or spinal anaesthesia
- Uncorrectable coagulopathy (INR \>1.5, platelet \<50×10⁹/L) or anticoagulant/antiplatelet therapy that cannot be stopped (low-dose aspirin 80-100 mg is permitted)
- Active urinary tract infection or acute prostatitis
- MRI-invisible focus located in a region where focal therapy would likely cause sphincter or rectal injury, as determined by biopsy mapping and anatomical constraints
- Bladder pathology (bladder stone, bladder cancer) or known urethral stricture
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。