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

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06824259
• Lead Sponsor: Peking University First Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Study Start: 2025-03-01
• Primary Completion: 2028-12-31
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The clinically significant prostate cancer (csPCa) detection rate	One month after the biopsy procedure.	csPCa was defined as PCa with a grade group \> 2 or GS ≥ 7. The reference standard was the pathological result.

Secondary Outcome Measures

Name	Time	Method
The Gleason score (GS) of the biopsy sample	One month after the biopsy procedure.	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.
The PCa detection rate	One month after the biopsy procedure.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China