The Value of Dual-parametric Magnetic Resonance Combined With Regional Saturation Biopsy in Patients With Suspected Prostate Cancer

N/AActive Not RecruitingNCT06824259

Peking University First Hospital400 enrolled

Overview

The aim of this study was to investigate the value of dual-parameter magnetic resonance imaging(bpMRI) combined with regional saturation biopsy in the diagnosis of prostate cancer by means of a prospective randomized controlled study. The main questions it aims to answer are: Can bpMRI guide the timing of prostate puncture and avoid unnecessary prostate biopsy? Effectiveness of focal saturation biopsy versus systemic biopsy + targeted biopsy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

400

Conditions

Prostate Cancer

Interventions

Follow up if MRI is negativePROCEDURE

Enter the follow-up cohort without systematic biopsy when prostate cancer is clinically suspected and no PIRADS v2.1 score ≥3 lesions are detected on initial examination. MR plus regional saturation biopsy was performed when MRI progressed.

Systematic biopsy if MRI is negativePROCEDURE

Systematic biopsy was performed if there was clinical suspicion of prostate cancer and no PIRADS v2.1 score ≥3 lesions were detected on initial examination. If the biopsy was negative enter the follow-up cohort.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be 18 years of age or older. 2. Compliance with clinical guidelines for indications for prostate puncture: * suspicious prostate nodule detected on rectal palpation; * suspicious lesion detected by transrectal ultrasound or magnetic resonance; * tPSA \> 10 ng/mL; * tPSA 4-10 ng/mL with f/t \< 0.16 or PSAD \> 0.15. 3. Complete sequence of bpMRI of the prostate at our institution; Exclusion Criteria: 1. tPSA \>50ng/mL; 2. Presence of contraindications to prostate puncture and inability to tolerate prostate puncture; 3. reatment with radiotherapy, chemotherapy and surgery before prostate puncture; 4. History of prostate cancer; 5. Prostate multiparametric magnetic resonance images of poor quality or some sequences are missing.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

The clinically significant prostate cancer (csPCa) detection rate

csPCa was defined as PCa with a grade group \> 2 or GS ≥ 7. The reference standard was the pathological result.

Time frame: One month after the biopsy procedure.

Secondary Outcomes

The Gleason score (GS) of the biopsy sample

The Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade.

Time frame: One month after the biopsy procedure.

The PCa detection rate

Time frame: One month after the biopsy procedure.

Data from ClinicalTrials.gov

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