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

Sponsor

Anhui Provincial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05940415

Collaborator

Zhongda Hospital (Other), Yijishan Hospital of Wannan Medical College (Other), Wuhu City Second People's Hospital (Other)

800

Enrollment

Location

35.4

Anticipated Duration (Months)

22.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Behavioral: active surveillance

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Jul 20, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Patients with low-risk of prostate cancer based on USTC diagnostic model

Predictive probability was less than 0.05 based on USTC diagnostic model (https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/).

Behavioral: active surveillance

active surveillance without prostate biopsy

Outcome Measures

Primary Outcome Measures

prostate cancer diagnostic free survival time [through study completion, an average of 2 year]
survival analysis by K-M curves and log-rank tests

Secondary Outcome Measures

dynamic change of serum total PSA [every 3 months up to 2 years]
dynamic change serum PSA level after active surveillance
dynamic change of PI-RADS score [every 3 months up to 2 years]
dynamic change PI-RADS score after active surveillance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.