Comparing two methods for prostate cancer biopsy detection
Non-inferiority Randomized Controlled Trial of Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy
This study is testing if a new way of doing prostate cancer biopsies by using a doctor's judgment is just as good as using computer software for men who might have significant prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 626 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Shanghai East Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04271527 on ClinicalTrials.gov |
What this trial studies
This trial is a prospective, multi-centre, randomized controlled, and non-inferiority study that compares cognitive fusion targeted biopsy with software-based fusion targeted biopsy in men suspected of having clinically significant prostate cancer. The goal is to determine if the cognitive method is as effective as the software method in detecting significant cancer cases. Participants will be men over 18 with elevated PSA levels or abnormal digital rectal exams. The study will assess the detection rates of clinically significant cancer between the two biopsy techniques.
Who should consider this trial
Good fit: Ideal candidates are men over 18 with PSA levels between 4-20 ng/ml or abnormal digital rectal exams.
Not a fit: Patients with acute or chronic prostatitis, contraindications to prostate biopsy or MRI, or other disqualifying conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve prostate cancer detection methods, leading to better patient outcomes.
How similar studies have performed: Other studies have explored similar biopsy techniques, but this specific comparison of cognitive versus software-based methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 18 2. PSA increase to 4-20 ng/ml and/or abnormal DRE; 3. Sign the informed consent Exclusion Criteria: 1. Have acute or chronic prostatitis 2. Contraindications to prostate biopsy 3. Contraindications to MRI 4. Other reasons that not suitable for this trial
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai East Hospital, Tongji University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Haifeng Wang, MD — Shanghai East Hospital,Tongji University School of Medicine
- Study coordinator: Biming He, MD
- Email: 190589109@qq.com
- Phone: +8615502139410
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.