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Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer

NCT05940415 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2024-01-31

No results posted yet for this study

Summary

The goal of this observational study is to evaluate the role of the USTC diagnostic model in risk-adaptive strategies for biopsy decision-making in patients with low-risk suspected prostate cancer in order to reduce unnecessary biopsy. Based on the USTC diagnostic model (website: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) and serum PSA levels, patients with low-risk suspected prostate cancer are enrolled and received active surveillance rather than biopsy. The main questions to be answered is:

• The safety and feasibility of conducting biopsy-free active monitoring in patients with low-risk suspected prostate cancer accessed by the USTC diagnostic model and serum PSA levels.

Participants will be required to undergo serum PSA testing every 3 months, mpMRI testing every 6 months, and reassessment of the probability of developing prostate cancer using the USTC model every 3 months. Patients who do not meet the inclusion criteria and are at increased risk will no longer receive active surveillance and will be advised to undergo biopsy. Dynamic changes in PI-RADS score and biopsy results will also be recorded.

Conditions

Interventions

BEHAVIORAL

active surveillance

active surveillance without prostate biopsy

Sponsors & Collaborators

  • Zhongda Hospital

    collaborator OTHER

  • Wannan Medical College Yijishan Hospital

    collaborator OTHER

  • Wuhu City Second People's Hospital

    collaborator OTHER

  • Anhui Provincial Hospital

    lead OTHER_GOV

Principal Investigators

  • Tao Tao · The First Affiliated Hospital of USTC

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-08
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05940415 on ClinicalTrials.gov