Personalized Optimization of Systematic Prostate Biopsy
ConditionProstate Adenocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-95
SponsorFujian Medical University Union Hospital
About this trial
Targeted biopsy combined systematic biopsy is the gold standard for diagnosis of prostate cancer. Excessive cores in systematic biopsy increases the risk of puncture trauma， bleeding and infection. On the basis of establishing a model with DRS stratification to reduce the cores of systematic biopsy, we propose the (12 cores -x) model innovatively. We hope that through this prospective study to verify the efficacy of the model and provide patients with a new biopsy model with high accuracy and fewer complications.
In this study， patients with suspected prostate cancer were randomly divided into two groups. Experimental group received targeted biopsy combined personalized systematic biopsy, and the control group received systematic biopsy .The differences of the detection rate of Prostate cancer between the two groups were compared.
Eligibility criteria
Qualifiers
Patients with lesions found on rectal examination with any PSA value;
Patients with abnormal lesions found on imaging with any PSA value;
PSA >10.0 ng.ml-1;
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
Disqualifiers
previous biopsy cases;
Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy;
Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound
clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention.
Trial design
Treatments tested in this trial
- Personalized Optimization of Systematic Prostate Biopsy
Treatment groups
330 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov