The Value of Dual-parametric Magnetic Resonance Combined With Regional Saturation Biopsy in Diagnostic Decision-making in Patients With Suspected Prostate cancer--a Single-center Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The clinically significant prostate cancer (csPCa) detection rate
研究概览
简要总结
The aim of this study was to investigate the value of dual-parameter magnetic resonance imaging(bpMRI) combined with regional saturation biopsy in the diagnosis of prostate cancer by means of a prospective randomized controlled study.
The main questions it aims to answer are:
Can bpMRI guide the timing of prostate puncture and avoid unnecessary prostate biopsy? Effectiveness of focal saturation biopsy versus systemic biopsy + targeted biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age or older.
- •Compliance with clinical guidelines for indications for prostate puncture:
- •suspicious prostate nodule detected on rectal palpation;
- •suspicious lesion detected by transrectal ultrasound or magnetic resonance;
- •tPSA > 10 ng/mL;
- •tPSA 4-10 ng/mL with f/t < 0.16 or PSAD > 0.
- •Complete sequence of bpMRI of the prostate at our institution;
排除标准
- •tPSA >50ng/mL;
- •Presence of contraindications to prostate puncture and inability to tolerate prostate puncture;
- •reatment with radiotherapy, chemotherapy and surgery before prostate puncture;
- •History of prostate cancer;
- •Prostate multiparametric magnetic resonance images of poor quality or some sequences are missing.
研究组 & 干预措施
MRI negative without biopsy
If a lesion with a PI-RADS score of 3 or higher was identified during the initial examination, a regional saturation biopsy of the prostate was conducted, as clinical suspicion of prostate cancer had been raised. Should the initial prostate biopsy yield negative results, the patient would be placed in the follow-up cohort. Targeted biopsy in conjunction with a 12-needle systematic biopsy would only be performed in cases where there was high suspicion of MRI persistence (a PI-RADS v2.1 score of 4 or 5) or if the lesion showed signs of progression. If no lesions with a PI-RADS v2.1 score of 3 or higher were detected during the initial examination, the patients would be entered into the follow-up cohort. Reginal saturation biopsy would be performed when MRI showed progression. If the initial prostate biopsy was negative, the patient would again be entered into the follow-up cohort.
干预措施: Follow up if MRI is negative (Procedure)
MRI negative with systemic biopsy
Focal saturation biopsy of the prostate was performed if a PI-RADS v2.1 score ≥3 lesion was detected during the initial examination. If no PIRADS v2.1 score ≥3 lesions were identified, a 12-needle systematic biopsy was performed. If the initial prostate biopsy was negative for prostate cancer, it was entered into the follow-up cohort. When the following clinical indications for repeat biopsy were met ① initial biopsy pathology showed no evidence of malignancy, but atypical small follicular hyperplasia was found, or high-grade epithelial neoplasia in more than 3 needles, with atypical glands visible in the surrounding area present; ② review of persistent elevation of serum PSA or abnormalities in the imaging follow up; and ③ review of serum PSA 4~10 ng/ml in conjunction with f/t PSA, PSAD, PSAV, and PHI, abnormal rectal digital examination or other imaging findings, then target biopsy combined with 12-needle systemic biopsy was performed.
干预措施: Systematic biopsy if MRI is negative (Procedure)
结局指标
主要结局
The clinically significant prostate cancer (csPCa) detection rate
时间窗: One month after the biopsy procedure.
csPCa was defined as PCa with a grade group \> 2 or GS ≥ 7. The reference standard was the pathological result.
次要结局
- The Gleason score (GS) of the biopsy sample(One month after the biopsy procedure.)
- The PCa detection rate(One month after the biopsy procedure.)