Actively Recruiting
Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer
Led by Anhui Provincial Hospital · Updated on 2024-01-31
220
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
Sponsors
A
Anhui Provincial Hospital
Lead Sponsor
Z
Zhongda Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with clinically suspected prostate cancer who have indications for prostate biopsy
- Complete serum PSA testing and multiparametric MRI examination in the outpatient setting
- Serum total PSA between 4 ng/ml and 10 ng/ml
- Probability of prostate cancer less than 0.05 according to the USTC diagnostic model
- No family history of prostate cancer and no history of other malignant tumors
You will not qualify if you...
- Previous history of prostate biopsy
- Incomplete clinical information, including failure to perform multiparametric MRI
- Serum total PSA less than 4 ng/ml or greater than 10 ng/ml
- Probability of prostate cancer equal to or greater than 0.05 according to the USTC diagnostic model
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of USTC
Hefei, Anhui, China, 230001
Actively Recruiting
Research Team
T
Tao Tao
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here