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

University of Science and Technology of China (USTC)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Behavioral: active surveillance

Study type: Observational

Funder types: Other

Identifiers

NCT05940415

SNOTOB-II

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

220 participants in 1 patient group

Patients with low-risk of prostate cancer based on USTC diagnostic model and serum PSA levels.

Description:

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/).

Treatment:

Behavioral: active surveillance