Pathological Positivity Rate in Prostate Cancer Patients with PI-RADS 4 and First Negative Biopsy

A Prospective Clinical Study Based on USTC Diagnostic Model and PSMA/PET-CT for Direct Radical Prostatectomy in Some Patients with First Negative Biopsy

The purpose of this prospective, single-center, single-arm trial was to evaluate the pathologic type of re-treatment based on a clear PI-RADS score of ≥4 with a first negative prostate biopsy, belonging to the high-risk group of the USTC diagnostic model, and PSMA PET/CT positive patients, and to evaluate the diagnostic efficacy of the USTC diagnostic model combined with PSMA PET/CT. At the same time, to explore whether these patients can directly undergo radical prostatectomy without repeated puncture.

Firstly, patients with PI-RADS≥4 scores were screened and the first prostate biopsy was negative. Then USTC diagnostic model was used to evaluate the risk probability of patients suffering from csPCa to determine whether the patients belonged to the high-risk group. Then PSMA/PET-CT was improved for patients in high-risk group to identify the positive lesions of prostate. Finally, for patients with ≥4 PI-RADS and negative prostate aspiration for the first time, Laparoscopic radical prostatectomy (LRP) was performed compared with high-risk groups of USTC diagnostic model and positive PSMA PET/CT. Transperineal targeted prostate biopsy was performed if intraoperative freeze pathology indicated prostate cancer, then LRP was performed; intraoperative freeze pathology indicated benign prostate biopsy, then transperineal prostate biopsy was performed.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer

Detailed Description

Research design This is a prospective, single-center, single-arm, open-label clinical study conducted at the First Affiliated Hospital of the University of Science and Technology of China. Patients with no contraindications to surgery and who meet enrollment criteria will be included in the study. Subsequently, the investigators will recommend that these patients be treated again for PI-RADS≥4, first negative prostate puncture, high-risk group of USTC diagnostic model, and PSMA PET/CT positive patients. Laparoscopic radical prostatectomy (LRP) was directly performed. Transperineal targeted prostate biopsy was performed if intraoperative freeze pathology indicated prostate cancer, then LRP was performed; intraoperative freeze pathology indicated benign prostate biopsy, then transperineal prostate biopsy was performed.

The diagnostic efficacy of USTC diagnostic model combined with PSMA PET/CT was evaluated according to the pathological results of LRP postoperative specimens or prostate biopsy specimens, and whether such patients can directly undergo radical prostatectomy without repeated puncture was also discussed. Before surgery, patients and their families should be fully informed of the surgical risks, the necessity of pathologic confirmation of prostate biopsy, the possibility of benign prostate lesions, and other alternative treatments, including active monitoring, radiotherapy, and focal therapy.

Screening and registration This study consisted of a prostate cancer diagnostic model and a tandem examination of 18F-Prostate-specific membrane antigen 1007 positron emission tomography/computed tomography (18F-PSMA-1007 PET/CT).

For patients with PI-RADS≥4 and negative prostate puncture for the first time, the prostate magnetic resonance score was re-evaluated three months later. For patients with PI-RADS still ≥4, the serum prostate-specific antigen (PSA) test and multi-parameter magnetic resonance imaging (mpMRI) were completed. Prostate-specific antigen density (PSAD) and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v2.1) score information were obtained. Then through online diagnosis chart (website: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) patients with clinically significant probability of the risk of prostate cancer (csPCa). When the csPCa prediction probability is equal to or greater than 0.60, 18F-PSMA-1007 PET/CT is used for further diagnosis. If a patient is still considered to have csPCa after an 18F-PSMA-1007 PET/CT examination, the investigators define this as a positive result. These patients met our study criteria. Notably, patients with a predicted probability of less than 0.60 will no longer receive 18F-PSMA-1007 PET/CT, and patients with a risk probability equal to or greater than 0.60 but negative 18F-PSMA-1007 PET/CT will not meet the inclusion criteria.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Tao Tao, MD Ph.D; Phone Number: 18856069828; Email: taotao_urology@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • The First Affiliated Hospital of USTC
      • Contact: Tao Tao; Phone Number: 18856069828; Email: taotao_urology@ustc.edu.cn
      • Contact: Tao Tao, MD Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• PI-RADS≥4 scores and the first prostate biopsy was negative
• USTC clinical diagnosis model calculated risk probability value ≥0.6
• Reexamination of PSMA/PET-CT after the first puncture indicated positive prostatic lesions

Description

Inclusion Criteria:

• PI-RADS≥4 scores and the first prostate biopsy was negative
• USTC clinical diagnosis model calculated risk probability value ≥0.6
• Reexamination of PSMA/PET-CT after the first puncture indicated positive prostatic lesions

Exclusion Criteria:

• Life expectancy is less than 15 years
• Multiple metastasis of tumor is possible
• There are serious cardiovascular and cerebrovascular diseases, bleeding tendencies and other surgical or puncture contraindications

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reexamination pathologic positive rate of target patients	2024-2025

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Study Chair: Tao Tao, MD Ph.D, The First Affiliated Hospital of USTC

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: November 3, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: prostate cancer; prostate specific antigen; prostate biopsy; mpMRI; diagnostic model; PI-ARDS
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SNOTOB-III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No