Personalized biopsy approach for prostate cancer diagnosis
Diagnostic Performance of a Individualized Reduced-Core Biopsy Strategy in Prostate Cancer: A Prospective, Randomized Controlled Study
NA · Fujian Medical University Union Hospital · NCT05998278
This study tests a new way to take fewer biopsy samples for diagnosing prostate cancer to see if it can still accurately find the disease while reducing complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 50 Years to 95 Years |
| Sex | Male |
| Sponsor | Fujian Medical University Union Hospital (other) |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT05998278 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a new personalized biopsy model for diagnosing prostate cancer, aiming to reduce the number of biopsy cores needed while maintaining diagnostic accuracy. Patients with suspected prostate cancer are randomly assigned to either an experimental group receiving a targeted biopsy combined with a personalized systematic biopsy or a control group receiving standard targeted biopsy combined with systematic biopsy. The study evaluates the efficacy of this new approach by comparing the cancer detection rates between the two groups. The goal is to minimize complications associated with excessive biopsy cores while ensuring accurate diagnosis.
Who should consider this trial
Good fit: Ideal candidates include men with suspected prostate cancer based on imaging or rectal examination findings and specific PSA levels.
Not a fit: Patients who have previously undergone prostate biopsies or surgeries, or those with severe systemic diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer complications and a more accurate diagnosis for patients suspected of having prostate cancer.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in optimizing biopsy techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with lesions found on rectal examination with any PSA value; 2. Patients with abnormal lesions found on imaging with any PSA value; 3. PSA \>10.0 ng.ml-1; 4. Patients with PSA of 4.0-10.0 ng.ml-1 and fPSA/tPSA \< 0.16; (5 ) mpMRI was performed prior to biopsy and Prostate Imaging Reporting and Data System (PI-RADS V2.1) assessment category ≥3 (6) Willing to truthfully fill in the subject survey scale; (7) Willing to undergo follow-up; (8) The patient himself or his authorized immediate family member has signed the informed consent for clinical trial. Exclusion Criteria: 1. previous biopsy cases; 2. Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy; 3. Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound 4. clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention. 5. unable to follow the plan.
Where this trial is running
Fuzhou, Fujian
- Department of Urology, Fujian Union Hospital, Fujian Medical University — Fuzhou, Fujian, China (RECRUITING)
Study contacts
- Principal investigator: Zhenlin Chen — Department of Urology, Fujian Union Hospital, Fujian Medical University
- Study coordinator: Jiabing Zheng
- Email: xhyykjk@163.com
- Phone: +8613799422519
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.
Conditions: Prostate Adenocarcinoma