Monitoring low-risk suspected prostate cancer without biopsy
Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer Based on USTC Diagnostic Model and PSA Level: a Multicenter Prospective Study
This study tests a new way to monitor men with low-risk suspected prostate cancer without immediate biopsy to see if it can safely reduce unnecessary procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT05940415 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the USTC diagnostic model's effectiveness in guiding biopsy decisions for patients with low-risk suspected prostate cancer. Participants will undergo active surveillance instead of immediate biopsy, with regular serum PSA testing and mpMRI assessments to monitor their condition. The study aims to determine the safety and feasibility of this biopsy-free approach, potentially reducing unnecessary procedures for patients. The USTC model will help assess the risk of developing prostate cancer based on individual patient data.
Who should consider this trial
Good fit: Ideal candidates are men with clinically suspected prostate cancer who have low serum PSA levels and a low probability of cancer according to the USTC diagnostic model.
Not a fit: Patients with a history of prostate biopsy or those at higher risk of prostate cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the number of unnecessary prostate biopsies for patients with low-risk suspected prostate cancer.
How similar studies have performed: While similar approaches to active surveillance have been explored, this specific method using the USTC diagnostic model is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hefei, Anhui
- The First Affiliated Hospital of USTC — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Tao Tao
- Email: taotao_urology@ustc.edu.cn
- Phone: 18856069828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.