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

NCT05670691 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 71

Last updated 2023-01-11

No results posted yet for this study

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Dingwei Ye, Doctor · Fudan University

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2024-12-31
Completion
2025-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05670691 on ClinicalTrials.gov