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Diagnostic study on MRI-TRUS fusion imaging guided prostate cancer puncture biopsy

Diagnostic study on MRI-TRUS fusion imaging guided prostate cancer puncture biopsy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014502
Enrollment
Unknown
Registered
2018-01-17
Start date
2018-02-12
Completion date
Unknown
Last updated
2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

Gold Standard:For patients who received the operation, operative pathology was used as the gold standard
for patients who did not receive the operation, the final diagnosis of one year follow-up was used as the gold standard.
Index test:MRI-TRUS&#32
combined&#32
with&#32
systematic&#32

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged = 18 years old; (2) Serum PSA was = 4ng/ml due to unexplained reasons; (3) Suspected nodules were detected by initial rectal ultrasound or MRI examination; (4) Patients that had not received puncture biopsy; (5) Patients were able to understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Acute prostatitis; (2) Coagulation dysfunction; (3) Low immune function; (4) Anal fistula or colorectal condition that did not allow puncture biopsy; (5) There were other serious diseases that were not suitable for puncture biopsy; (6) the mental state was not suitable; (7) Patients with pacemaker or automatic implantable defibrillator; (8) Patients with allergies to any known adhesives or latex.

Design outcomes

Primary

MeasureTime frame
Percentage of high-risk patients (for all punctured tissues, Gleason score =4+3 was high risk; for postoperative pathological examination, tissues with Gleason score =4+3 were high risk);

Secondary

MeasureTime frame
Percentage of moderate risk patients (for targeted puncture tissues, =50% tissues with Gleason score=4+3; for systematic puncture tissues, =33% tissues with Gleason score=4+3; for postoperative pathological examination, =20% tissues with Gleason score=4+3).;Percentage of low risk patients (for targeted puncture tissues, <50% tissues with Gleason score=4+3 or Gleason score<7; for systematic puncture tissues, <33% tissues with Gleason score=4+3 or Gleason score<7; for postoperative pathological examination, <20% tissues with Gleason score=4+3 or Gleason score<7).;Preoperative anxiety (Amsterdam preoperative anxiety and information scale, APAIS);Pain score (VRS score);Disease progress: tumor size, lesion number, recurrence or not, recurrence time, metastasis or not, metastasis time, and etc.;

Countries

China

Contacts

Public ContactLigang Cui

Peking University Third Hospital

cuijuegang@126.com+86 13910627163

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026