a Study of Combined mpMRI and PSMA PET/CT for Highly Suspicious Patients Performing Radical Prostatectomy Without Biopsy

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.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

1. age ≥ 18 years.
2. consent and ability to complete a multiparametric MRI of the prostate.
3. consent and ability to complete PSMA PET/CT.
4. multiparametric MRI of the prostate with a PI-RADS score of 4 or 5 for suspicious lesions.
5. Positive PSMA PET/CT. Its positive is defined as a suspicious lesion score of 2 or 3 (see remarks for specific scoring criteria).
6. good physical condition with an ECOG score of 0 or 1.
7. no history of radiotherapy or other surgery to the pelvis
8. the presence of pelvic lymph node enlargement (\>2 cm) or metastasis is allowed; ≤5 bone and lymph node metastases are allowed
9. 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.
10. the patient participates voluntarily and has signed an informed consent form
11. the patient is able to receive treatment and subsequent follow-up
12. the expected survival time is greater than 1 year.

Exclusion Criteria:

1. unwillingness or inability to perform multiparametric MRI of the prostate; or PI-RADS score of 0-3
2. request for prostate puncture biopsy.
3. unwillingness or inability to perform PSMA PET/CT; or PSMA PET/CT score of 0 or 1
4. refusing radical prostate cancer surgery, or choosing other primary lesion treatment modalities other than radical prostate cancer surgery
5. poor physical condition that prevents them from tolerating radical prostate cancer surgery
6. More than 5 bone and lymph node metastases, visceral metastases
7. 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)
8. 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.
9. 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.)

• RESULTMeissner VH, Rauscher I, Schwamborn K, Neumann J, Miller G, Weber W, Gschwend JE, Eiber M, Heck MM. Radical Prostatectomy Without Prior Biopsy Following Multiparametric Magnetic Resonance Imaging and Prostate-specific Membrane Antigen Positron Emission Tomography. Eur Urol. 2022 Aug;82(2):156-160. doi: 10.1016/j.eururo.2021.11.019. Epub 2021 Dec 6. PMID 34887117
• RESULTEmmett L, Buteau J, Papa N, Moon D, Thompson J, Roberts MJ, Rasiah K, Pattison DA, Yaxley J, Thomas P, Hutton AC, Agrawal S, Amin A, Blazevski A, Chalasani V, Ho B, Nguyen A, Liu V, Lee J, Sheehan-Dare G, Kooner R, Coughlin G, Chan L, Cusick T, Namdarian B, Kapoor J, Alghazo O, Woo HH, Lawrentschuk N, Murphy D, Hofman MS, Stricker P. The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study. Eur Urol. 2021 Dec;80(6):682-689. doi: 10.1016/j.eururo.2021.08.002. Epub 2021 Aug 28. PMID 34465492
• RESULTChen M, Zhang Q, Zhang C, Zhou YH, Zhao X, Fu Y, Gao J, Zhang B, Wang F, Qiu X, Guo H. Comparison of 68Ga-prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) and multi-parametric magnetic resonance imaging (MRI) in the evaluation of tumor extension of primary prostate cancer. Transl Androl Urol. 2020 Apr;9(2):382-390. doi: 10.21037/tau.2020.03.06. PMID 32420143
• RESULTYang FY, Li YJ, Han SJ, Chen D, Wu LY, Xiao ZJ, Li CL, Xing NZ. [The preliminary clinical study on radical prostatectomy without preoperative prostate biopsy]. Zhonghua Yi Xue Za Zhi. 2020 Sep 15;100(34):2658-2662. doi: 10.3760/cma.j.cn112137-20200104-00021. Chinese. PMID 32921013
• RESULTMoldovan PC, Van den Broeck T, Sylvester R, Marconi L, Bellmunt J, van den Bergh RCN, Bolla M, Briers E, Cumberbatch MG, Fossati N, Gross T, Henry AM, Joniau S, van der Kwast TH, Matveev VB, van der Poel HG, De Santis M, Schoots IG, Wiegel T, Yuan CY, Cornford P, Mottet N, Lam TB, Rouviere O. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol. 2017 Aug;72(2):250-266. doi: 10.1016/j.eururo.2017.02.026. Epub 2017 Mar 21.