NCT05940415 Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer
| NCT ID | NCT05940415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anhui Provincial Hospital |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-10-08 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2023-10-08 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Tao Tao
STUDY CHAIR
The First Affiliated Hospital of USTC
Frequently Asked Questions
Who can join the NCT05940415 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05940415 currently recruiting?
Yes, NCT05940415 is actively recruiting participants. Contact the research team at taotao_urology@ustc.edu.cn for enrollment information.
Where is the NCT05940415 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT05940415 clinical trial?
NCT05940415 is sponsored by Anhui Provincial Hospital. The principal investigator is Tao Tao at The First Affiliated Hospital of USTC. The trial plans to enroll 220 participants.
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