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

NCT05670691 | Unknown

• 1 other identifier: FUSCC RP without biopsy
• Study Type: observational
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostatic Neoplasms; Prostatectomy; Prostate Biopsy

Keywords

MRI; PSMA PET/CT; prostate biopsy

Outcome Measures

Primary Outcomes (1)

• The positive rate of pathological diagnosis of prostate cancer

  The positive rate of pathological diagnosis of prostate cancer from tissue of prostatectomy for the all the participants.

  two years

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Robotic-assisted laparoscopic radical prostate cancer surgery is recommended for this group of patients. Ultimately, the presence or absence of evidence of malignant prostate cancer on the pathology report after radical prostatectomy is used as an observational endpoint in this study. Relevant perioperative clinicopathological data are also collected according to the study objectives.

You may qualify if:

• 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 1.
• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Fudan University: lead

Related Publications (6)

• Meissner 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 RESULT

• Emmett 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 RESULT

• Chen 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 RESULT

• Yang 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 RESULT

• Moldovan 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.

  PMID: 28336078 RESULT

• Eiber M, Weirich G, Holzapfel K, Souvatzoglou M, Haller B, Rauscher I, Beer AJ, Wester HJ, Gschwend J, Schwaiger M, Maurer T. Simultaneous 68Ga-PSMA HBED-CC PET/MRI Improves the Localization of Primary Prostate Cancer. Eur Urol. 2016 Nov;70(5):829-836. doi: 10.1016/j.eururo.2015.12.053. Epub 2016 Jan 18.

  PMID: 26795686 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dingwei Ye, Doctor

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Guowen Lin, doctor

CONTACT

86-021-6175590; guowenlin@urocancer.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: January 4, 2023
• Study Start: January 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share