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Trial Title:
Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer
NCT ID:
NCT05940415
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
prostate cancer
prostate biospy
mpMRI
prostate specific antigen density
diagnostic model
active surveillance
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
active surveillance
Description:
active surveillance without prostate biopsy
Arm group label:
Patients with low-risk of prostate cancer based on USTC diagnostic model and serum PSA levels.
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.
Criteria for eligibility:
Study pop:
We select patients with low-risk suspected prostate cancer evaluated by USTC diagnostic
model and serum PSA level. After meeting the inclusion criteria, follow-up surveys will
be conducted.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of USTC
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Tao
Phone:
18856069828
Email:
taotao_urology@ustc.edu.cn
Investigator:
Last name:
Tao Tao, MD Ph.D
Email:
Principal Investigator
Start date:
October 8, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Zhongda Hospital
Agency class:
Other
Collaborator:
Agency:
Yijishan Hospital of Wannan Medical College
Agency class:
Other
Collaborator:
Agency:
Wuhu City Second People's Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05940415
