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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Behavioral: active surveillance

• Registration Number: NCT05940415
• Lead Sponsor: Anhui Provincial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-07-07
• Study First Posted: 2023-07-11
• Study Start: 2023-10-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 220

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with low-risk of prostate cancer based on USTC diagnostic model and serum PSA levels.	active surveillance	Patients with PSA between 4 to 10 ng/ml and USTC model predicted probability of cancer less than 0.05 (https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
dynamic change of PI-RADS score	every 6 months up to 2 years	dynamic change PI-RADS score after active surveillance
dynamic change of serum total PSA	every 3 months up to 2 years	dynamic change serum PSA level after active surveillance

Trial Locations

Locations (1)

The First Affiliated Hospital of USTC; 🇨🇳 Hefei, Anhui, China