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

Anhui Provincial Hospital220 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Prostate Cancer

Interventions

active surveillance

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

prostate cancer diagnostic free survival time

survival analysis by K-M curves and log-rank tests

Time frame: through study completion, an average of 2 year

Secondary Outcomes

dynamic change of serum total PSA

dynamic change serum PSA level after active surveillance

Time frame: every 3 months up to 2 years

dynamic change of PI-RADS score

dynamic change PI-RADS score after active surveillance

Time frame: every 6 months up to 2 years