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NCT Number: NCT06824259

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The clinically significant prostate cancer (csPCa) detection rate

    Time frame: 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 outcomes

  1. The Gleason score (GS) of the biopsy sample

    Time frame: 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.

  2. The PCa detection rate

    Time frame: One month after the biopsy procedure.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

The Value of Dual-parametric Magnetic Resonance Combined With Regional Saturation Biopsy in Diagnostic Decision-making in Patients With Suspected Prostate cancer--a Single-center Prospective Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Feb 13, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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