Evaluating prostate cancer treatment in patients with negative biopsies and high PI-RADS scores
A Prospective Clinical Study Based on USTC Diagnostic Model and PSMA/PET-CT for Direct Radical Prostatectomy in Some Patients with First Negative Biopsy
This study is testing if men with high PI-RADS scores and a negative first biopsy can safely skip more biopsies and go straight to surgery for prostate cancer treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | N/A to 75 Years |
| Sex | Male |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06677775 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the pathological outcomes of prostate cancer patients who have a PI-RADS score of 4 or higher and a negative first biopsy. It utilizes the USTC diagnostic model to evaluate the risk of clinically significant prostate cancer (csPCa) and employs PSMA PET/CT imaging to identify positive lesions. The study will determine if these patients can proceed directly to laparoscopic radical prostatectomy without undergoing additional biopsies. The effectiveness of the combined diagnostic approach will be evaluated based on postoperative pathological results.
Who should consider this trial
Good fit: Ideal candidates are men with a PI-RADS score of 4 or higher who have had a negative first prostate biopsy and meet the risk criteria of the USTC diagnostic model.
Not a fit: Patients with a life expectancy of less than 15 years or those with serious comorbidities that contraindicate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could streamline treatment for high-risk prostate cancer patients by reducing unnecessary biopsies and expediting surgical intervention.
How similar studies have performed: While this study employs a novel combination of diagnostic tools, similar approaches in other studies have shown promise in improving diagnostic accuracy and treatment pathways for prostate cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PI-RADS≥4 scores and the first prostate biopsy was negative * USTC clinical diagnosis model calculated risk probability value ≥0.6 * Reexamination of PSMA/PET-CT after the first puncture indicated positive prostatic lesions Exclusion Criteria: * Life expectancy is less than 15 years * Multiple metastasis of tumor is possible * There are serious cardiovascular and cerebrovascular diseases, bleeding tendencies and other surgical or puncture contraindications
Where this trial is running
Hefei, Anhui
- The First Affiliated Hospital of USTC — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Tao Tao, MD Ph.D
- 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.