Clinical trial NCT05998278: Personalized Optimization of Systematic Prostate Biopsy
Official title: Research on Building "3+12-X" Personalized Prostate Precise Puncture Model with DRS Layered As the Core Based on Big Data MRI Images
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Adenocarcinoma
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 664
Sex: MALE
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: They were randomly divided into two groups. One group received targeted biopsy plus systematic biopsy. The other group received targeted biopsy plus plus personalized systematic biopsy.
Primary purpose: DIAGNOSTIC

Brief summary: 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 targeted biopsy combined systematic biopsy. The differences of the detection rate of Prostate cancer between the two groups were compared.

Detailed description: In this study, patients with suspected prostate cancer were were enrolled at our institution, a public referral tertiary center. After written consent was obtained， patients were randomly assigned to either the intervention or control group in a 1:1 ratio using SPSS software by a research nurse with no clinical involvement in the trial. Once the allocation was established, neither patients nor investigators, including the member of the study who collected the data related to infectious events later, were blinded. Prior to biopsy, the following patient characteristics were obtained: age, BMI, serum PSA levels, location and size of the region of interest, and PIRADS-V2 score. Biopsy was performed by an experienced urologist using standard transperineal technique. The patient was placed in the lithotomy position and underwent either general anesthesia or local anesthesia (15 ml of 5% lidocaine was injected into the prostate capsule and apex under ultrasound guidance after the ultrasound probe was inserted transrectally for local anesthesia). Patients assigned to the experimental group were informed of the personalized systematic biopsy combined with targeted biopsy using the (12 cores -x) model (https://daringsky.shinyapps.io/prediction_v2/)， and the control group received targeted biopsy combined systematic biopsy. A biopsy core was obtained using an 18-gauge 25cm needle and a spring needle biopsy gun. The primary endpoint was the rate of prostate cancer diagnosis, including clinically significant cases. The secondary endpoints included pain scores and complications such as hematuria, perineal hematoma, urinary tract infection, and urinary retention.

Eligibility 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.

Primary outcomes:
measure: The detection rate of prostate cancer.
timeFrame: 3 months after biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Urology, Fujian Union Hospital, Fujian Medical University
state: Fujian
Study officials:
affiliation: Department of Urology, Fujian Union Hospital, Fujian Medical University
name: Zhenlin Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen Z, Qu M, Shen X, Jiang S, Zhang W, Ji J, Wang Y, Zhang J, Chen Z, Lin L, Li M, Wu C, Gao X. Establishment of an Individualized Predictive Model to Reduce the Core Number for Systematic Prostate Biopsy: A Dual Center Study Based on Stratification of the Disease Risk Score. Front Oncol. 2022 Feb 14;11:831603. doi: 10.3389/fonc.2021.831603. eCollection 2021.