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

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to conduct an active surveillance without prostate biopsy for patients with low-risk of prostate cancer based on USTC diagnostic model in participant population. The main questions it aims to answer is: • The safety and feasibility of conducting biopsy free active monitoring in patients with low-risk prostate cancer evaluated by the USTC diagnostic model. Participants will need to detect serum PSA every 3 months. Dynamic change of PI-RADS score and biopsy results will be recorded too.

Official Title
-----------------
Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk of Prostate Cancer Based on USTC Diagnostic Model: a Multicenter Prospective Study

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: active surveillance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinically suspected PCa have indications for prostate biopsy; Complete serum PSA testing and mpMRI examination in the outpatient department; 4 ng/ml ≤ serum total PSA < 100 ng/ml; The probability of prostate cancer calculated by USTC diagnostic models is less than 0.05; There is no family history of prostate cancer and no history of other malignant tumors. Exclusion Criteria: The patient has previous history of prostate biopsy; Lack of complete clinical information, such as failure to perform mpMRI; Patients with serum total PSA < 4ng/ml or > 100ng/ml. According to USTC diagnostic model, the probability of prostate cancer is equal or more than 0.05.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with low-risk of prostate cancer based on USTC diagnostic model<br>Predictive probability was less than 0.05 based on USTC diagnostic model (https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/). | Behavioral: active surveillance<br>* active surveillance without prostate biopsy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate cancer diagnostic free survival time | survival analysis by K-M curves and log-rank tests | through study completion, an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dynamic change of serum total PSA | dynamic change serum PSA level after active surveillance | every 3 months up to 2 years | 
| dynamic change of PI-RADS score | dynamic change PI-RADS score after active surveillance | every 3 months up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate biospy, prostate cancer, mpMRI, prostate specific antigen density, diagnostic model, active surveillance