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Clinical study of radical prostatectomy without biopsy for highly suspicious localized prostate cancer based on combined diagnosis of mpMRI and artificial intelligence

Clinical study of radical prostatectomy without biopsy for highly suspicious localized prostate cancer based on combined diagnosis of mpMRI and artificial intelligence

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052525
Enrollment
Unknown
Registered
2021-10-30
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Prostate Cancer

Interventions

experimental group:No prostate biopsy before radical prostatectomy

Sponsors

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 60 to 80 years; 2. PI-RADS V2 5; 3. Preoperative mpMRI and emission computed tomography indicating clinical stage T1-T3bN0-1M0; 4. Patients refusing prostate biopsy and initiatively requiring RARP with or without pelvic lymph node dissection; 5. Meet surgical indications of prostatic hyperplasia; 6. Without history of other malignancies; 7. Without serious contraindications to surgery such as cardiopulmonary disease, ECOG score 0-1.

Exclusion criteria

Exclusion criteria: Patients unwilling to accept potential negative postoperative pathology or erectile dysfunction.

Design outcomes

Primary

MeasureTime frame
Postoperative pathological classification;Postoperative pathological lesion size;Postoperative pathological lesion location;Postoperative pathological margins;Postoperative pathological Gleason score;

Secondary

MeasureTime frame
International Prostate Symptom Score;Quality of Life Score;International Index of Erectile Function;

Countries

China

Contacts

Public ContactWang Zengjun

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

zengjunwang@njmu.edu.cn+86 13776612971

Outcome results

None listed

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