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

NCT06824259 | Active Not Recruiting

• 1 other identifier: bpMRIRSB
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  One month after the biopsy procedure.

Secondary Outcomes (2)

• The Gleason score (GS) of the biopsy sample

  One month after the biopsy procedure.

• The PCa detection rate

  One month after the biopsy procedure.

Study Arms (2)

MRI negative without biopsy

EXPERIMENTAL

If a lesion with a PI-RADS score of 3 or higher was identified during the initial examination, a regional saturation biopsy of the prostate was conducted, as clinical suspicion of prostate cancer had been raised. Should the initial prostate biopsy yield negative results, the patient would be placed in the follow-up cohort. Targeted biopsy in conjunction with a 12-needle systematic biopsy would only be performed in cases where there was high suspicion of MRI persistence (a PI-RADS v2.1 score of 4 or 5) or if the lesion showed signs of progression. If no lesions with a PI-RADS v2.1 score of 3 or higher were detected during the initial examination, the patients would be entered into the follow-up cohort. Reginal saturation biopsy would be performed when MRI showed progression. If the initial prostate biopsy was negative, the patient would again be entered into the follow-up cohort.

Procedure: Follow up if MRI is negative

MRI negative with systemic biopsy

ACTIVE COMPARATOR

Focal saturation biopsy of the prostate was performed if a PI-RADS v2.1 score ≥3 lesion was detected during the initial examination. If no PIRADS v2.1 score ≥3 lesions were identified, a 12-needle systematic biopsy was performed. If the initial prostate biopsy was negative for prostate cancer, it was entered into the follow-up cohort. When the following clinical indications for repeat biopsy were met ① initial biopsy pathology showed no evidence of malignancy, but atypical small follicular hyperplasia was found, or high-grade epithelial neoplasia in more than 3 needles, with atypical glands visible in the surrounding area present; ② review of persistent elevation of serum PSA or abnormalities in the imaging follow up; and ③ review of serum PSA 4\~10 ng/ml in conjunction with f/t PSA, PSAD, PSAV, and PHI, abnormal rectal digital examination or other imaging findings, then target biopsy combined with 12-needle systemic biopsy was performed.

Procedure: Systematic biopsy if MRI is negative

Interventions

Follow up if MRI is negative PROCEDURE

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.

MRI negative without biopsy

Systematic biopsy if MRI is negative PROCEDURE

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.

MRI negative with systemic biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years of age or older.
• 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.
• Complete sequence of bpMRI of the prostate at our institution;

You may not qualify if:

• tPSA \>50ng/mL;
• Presence of contraindications to prostate puncture and inability to tolerate prostate puncture;
• reatment with radiotherapy, chemotherapy and surgery before prostate puncture;
• History of prostate cancer;
• Prostate multiparametric magnetic resonance images of poor quality or some sequences are missing.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 13, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (1)