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

  • Unknown
  • Observational
  • Fudan University
  • 18 Years -


Study Purpose

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.

Intervention

N/A

Eligibility Requirements

info icon age ≥ 18 years.

info icon consent and ability to complete a multiparametric MRI of the prostate.

info icon consent and ability to complete PSMA PET/CT.

info icon multiparametric MRI of the prostate with a PI-RADS score of 4 or 5 for suspicious lesions.

info icon Positive PSMA PET/CT. Its positive is defined as a suspicious lesion score of 2 or 3 (see remarks for specific scoring criteria).

info icon good physical condition with an ECOG score of 0 or 1.

info icon no history of radiotherapy or other surgery to the pelvis

info icon the presence of pelvic lymph node enlargement (\>2 cm) or metastasis is allowed; ≤5 bone and lymph node metastases are allowed

info icon 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.

info icon the patient participates voluntarily and has signed an informed consent form

info icon the patient is able to receive treatment and subsequent follow-up

info icon the expected survival time is greater than 1 year.

info icon unwillingness or inability to perform multiparametric MRI of the prostate; or PI-RADS score of 0-3

info icon request for prostate puncture biopsy.

info icon unwillingness or inability to perform PSMA PET/CT; or PSMA PET/CT score of 0 or 1

info icon refusing radical prostate cancer surgery, or choosing other primary lesion treatment modalities other than radical prostate cancer surgery

info icon poor physical condition that prevents them from tolerating radical prostate cancer surgery

info icon More than 5 bone and lymph node metastases, visceral metastases

info icon 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)

info icon 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.

info icon have participated in other clinical studies prior to enrollment.

info icon 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.)

Recruiting status

Unknown

Estimated enrollment

71

 
Study start date

Jan 10, 2023

Study end date

Mar 01, 2025

Last updated

Mar 23, 2025

Primary purpose

N/A

Design

Observational

Intervention

Study phase

N/A

Allocation

N/A

 

Sponsor:

Fudan University

Collaborator:

N/A

Investigator:

Dingwei Ye, Doctor

NCT05670691

Clinic Location Investigator Distance RECRUITING STATUS Contact