A Prospective, Staged, Exploratory Clinical Study of Combined Multiparametric MRI and PSMA PET/CT for the Evaluation of Patients With High Suspicion of Prostate Cancer for Direct Radical Prostatectomy Without Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 71
- 主要终点
- The positive rate of pathological diagnosis of prostate cancer
研究概览
简要总结
This is an observational, open, single-arm, prospective, staged entry（based on Fleming's Group-Sequential Design） clinical study
The Goal is to evaluate the feasibility and clinical value of direct robot assisted laparoscopic radical prostatectomy without prostate biopsy in patients with high clinical suspicion of prostate cancer based on a prostate MRI PI-RADS score of ≥4 and the PSMA PET/CT positive criteria.
The Primary endpoint is positive pathological diagnosis of prostate cancer after direct radical prostatectomy without prostate biopsy.
The question addressed is whether the feasibility of biopsy-free radical prostatectomy could be scientifically and rationally derived based on Fleming's Group-Sequential design.
详细描述
Prostate biopsy is currently the key method for diagnosing prostate cancer. However, there are various risks associated with prostate biopsy. First, biopsy complications occur and usually include bleeding, infection, urinary retention, and vasovagal reflexes. Bleeding is one of the most common complications following prostate biopsy, with perineal biopsy hematuria occurring in 39%-44% of cases, rectal bleeding in 17%-27% of cases, and hematospermia in 12%-16% of cases. Infection is one of the more definite complications of prostate biopsy. The incidence is 5-12%. The probability of urinary retention after prostate biopsy is 0.5% to 1.7%. The vasovagal reflex is mainly characterized by a rapid drop in blood pressure, pallor, sweating, nausea, vomiting, chest tightness and, in severe cases, transient coma. The incidence is 0.9% to 16.7%. It is usually necessary to wait 2-4 weeks after biopsy before radical prostate cancer surgery can be performed. Therefore, timely treatment of the patient may be delayed. Second, the pain, anxiety and even fear associated with the biopsy are always with the patient. Third, the issuance of pathology reports generally takes 7-8 days and, if immunohistochemistry is involved, another 2 weeks, a long time with limited management of the full course of the disease, as well as patient attrition.
Multiparametric MRI (mpMRI) has a high tissue resolution and ideal specificity and sensitivity. mpMRI PI-RADS scores of 3, 4 and 5 were associated with a 35%, 60% and 91% diagnosis of prostate cancer, and furthermore, 17%, 34% and 67% diagnosis of CsPCa, respectively.
On the other hand, prostate-specific membrane antigen (PSMA) can specifically anchor prostate cancer cells and has a high sensitivity and specificity for detection.Studies have shown that 68Ga-PSMA PET/CT has a sensitivity of 88%-92% and a specificity of 92%-95% for the diagnosis of prostate cancer. In recent years, PET has also been combined with MRI to obtain many advantages in PET functional imaging as well as MRI imaging discrimination, which is more effective in improving the positive rate of impact diagnosis of prostate cancer.
The combined assessment of multiparametric MRI and PSMA PET/CT has greatly increased the likelihood of prostate cancer in people with multiple abnormalities, and on the other hand, the complications associated with prostate biopsy as well as the delay in surgery and the resulting increased difficulty of surgery. In December 2021, the European Journal of Urology first reported on radical surgery for prostate cancer without biopsy .
The investigators designed this clinical trial based on a combination of multiparametric MRI and PSMA PET/CT to evaluate patients with high suspicion of prostate cancer and make quantitative statistics. mpMRI and PSMA PET/CT were not only among the study parameters, but also could be satisfied with PSMA PET/CT, which was implemented after signing an informed consent after interpretation and performing a direct radical surgery without prostate biopsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age ≥ 18 years.
- •consent and ability to complete a multiparametric MRI of the prostate.
- •consent and ability to complete PSMA PET/CT.
- •multiparametric MRI of the prostate with a PI-RADS score of 4 or 5 for suspicious lesions.
- •Positive PSMA PET/CT. Its positive is defined as a suspicious lesion score of 2 or 3 (see remarks for specific scoring criteria).
- •good physical condition with an ECOG score of 0 or
- •no history of radiotherapy or other surgery to the pelvis
- •the presence of pelvic lymph node enlargement (>2 cm) or metastasis is allowed; ≤5 bone and lymph node metastases are allowed
- •the patient has good cardiac, pulmonary, hepatic and renal function and is able to tolerate local treatment (surgery or external radiotherapy) of the primary site and metastases, and the treatment will not cause serious complications for the patient.
- •the patient participates voluntarily and has signed an informed consent form
- •the patient is able to receive treatment and subsequent follow-up
- •the expected survival time is greater than 1 year.
排除标准
- •unwillingness or inability to perform multiparametric MRI of the prostate; or PI-RADS score of 0-3
- •request for prostate puncture biopsy.
- •unwillingness or inability to perform PSMA PET/CT; or PSMA PET/CT score of 0 or 1
- •refusing radical prostate cancer surgery, or choosing other primary lesion treatment modalities other than radical prostate cancer surgery
- •poor physical condition that prevents them from tolerating radical prostate cancer surgery
- •More than 5 bone and lymph node metastases, visceral metastases
- •history of combined other malignant tumors (except basal cell carcinoma of the skin or other tumors that have been cured for more than 5 years)
- •other serious medical conditions, such as: unstable heart disease after treatment, myocardial infarction within 6 months prior to treatment, cardiac function class 3-4 (NYHA); uncontrolled hypertension (>150/90 mmHg, severe neurological or psychological disorders including dementia or epilepsy) with medical treatment; uncontrolled active infection; acute gastric ulcer; hypercalcemia; chronic obstructive lung disease.
- •have participated in other clinical studies prior to enrollment.
- •Note: Positive PSMA PET/CT, defined as based on the miPSMA score scale suggested by the PROMISE Institute (score 0 - below the depth of blood contrast; score 1 - equal to or above the blood contrast and below the liver contrast; score 2 - equal to or above the liver contrast and below the parotid contrast; score 3 - equal to or above the liver parotid contrast.)
结局指标
主要结局
The positive rate of pathological diagnosis of prostate cancer
时间窗: two years
The positive rate of pathological diagnosis of prostate cancer from tissue of prostatectomy for the all the participants.
次要结局
未报告次要终点