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

NCT06677775 | Recruiting DMC

• 1 other identifier: SNOTOB-III
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; prostate biopsy; diagnostic model; mpMRI; prostate specific antigen; PI-ARDS

Outcome Measures

Primary Outcomes (1)

• Reexamination pathologic positive rate of target patients

  2024-2025

Eligibility Criteria

• Age: Up to 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

The First Affiliated Hospital of USTC

Hefei, Anhui, 230001, China

RECRUITING

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

• Tao Tao, MD Ph.D

  The First Affiliated Hospital of USTC

  STUDY CHAIR

Central Study Contacts

Tao Tao, MD Ph.D

CONTACT

18856069828; taotao_urology@ustc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Associate chief physician

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 7, 2024
• Study Start: August 30, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)