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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05940415

Acronym

ASWBP

Enrollment

220

Registered

2023-07-11

Start date

2023-10-08

Completion date

2026-06-30

Last updated

2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, prostate biospy, mpMRI, prostate specific antigen density, diagnostic model, active surveillance

Brief 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.

Interventions

BEHAVIORALactive surveillance

active surveillance without prostate biopsy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 6 months up to 2 years	dynamic change PI-RADS score after active surveillance

Countries

China

Contacts

Primary ContactTao Tao

taotao_urology@ustc.edu.cn18856069828

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026