RECRUITINGOBSERVATIONAL

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

Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer Based on USTC Diagnostic Model and PSA Level: a Multicenter Prospective Study

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients with clinically suspected PCa have indications for prostate biopsy; 2. Complete serum PSA testing and mpMRI examination in the outpatient department; 3. 4 ng/ml ≤ serum total PSA ≤10 ng/ml; 4. The probability of prostate cancer calculated by USTC diagnostic models is less than 0.05; 5. There is no family history of prostate cancer and no history of other malignant tumors. Who Should NOT Join This Trial: 1. The patient has previous history of prostate biopsy; 2. Lack of complete clinical information, such as failure to perform mpMRI; 3. Patients with serum total PSA \< 4ng/ml or \> 10ng/ml. 4. According to USTC diagnostic model, the probability of prostate cancer is equal or more than 0.05. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Patients with clinically suspected PCa have indications for prostate biopsy; 2. Complete serum PSA testing and mpMRI examination in the outpatient department; 3. 4 ng/ml ≤ serum total PSA ≤10 ng/ml; 4. The probability of prostate cancer calculated by USTC diagnostic models is less than 0.05; 5. There is no family history of prostate cancer and no history of other malignant tumors. Exclusion Criteria: 1. The patient has previous history of prostate biopsy; 2. Lack of complete clinical information, such as failure to perform mpMRI; 3. Patients with serum total PSA \< 4ng/ml or \> 10ng/ml. 4. According to USTC diagnostic model, the probability of prostate cancer is equal or more than 0.05.

Treatments Being Tested

BEHAVIORAL

active surveillance

active surveillance without prostate biopsy

Locations (1)

The First Affiliated Hospital of USTC

Hefei, Anhui, China