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Evaluation of tumor detection and biochemical recurrence in biopsy-free radical prostatectomy

Evaluation of tumor detection and biochemical recurrence in biopsy-free radical prostatectomy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071815
Enrollment
Unknown
Registered
2023-05-25
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

Prostate cancer

Interventions

Non-biopsy:Receiving radical prostatectomy without preoperative prostate biopsy
preoperative biopsy:Receiving radical prostatectomy with pathologically confirmed prostate cancer by preoperative prostate biopsy

Sponsors

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age > 60 2. The mpMRI indicated abnormal nodules (PI-RADS score >= 4) or PSMA PET/CT suspected tumor (PSMA-Rads score >= 4 and SUVmax >= 4) 3. Meet at least one of the four requirements: PSA>= 10ng/ml, 4ng/ml 0.20, PHI > 35 4. Clinical stage <= T4NxM0, and radical prostatectomy technically feasible 5. Can tolerate laparoscopic radical prostatectomy 6. Have the capacity of independent behavior and voluntarily sign the informed consent to be included in the group

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to surgery 2. Patients with a history of Prostate puncture or surgical 3. Patients with preoperative treatment including antitumor drugs for prostate cancer 4. Patients with Life expectancy less than 10 years 5. Patients with ECOG score > 2 6. Patients with poor compliance and other exclusion criteria identified by other researchers

Design outcomes

Primary

MeasureTime frame
Prostate cancer detection rate;biochemical recurrence ;

Secondary

MeasureTime frame
Surgical duration; Intraoperative bleeding volume;positive surgical margin;missed diagnosis ;ardent fever; Antibiotic usage days;Intraoperative intestinal injury; Postoperative urinary incontinence;Postoperative sexual function;hospitalization time;hospitalization cost;biomarker in immunohistochemical staining;

Countries

China

Contacts

Public ContactShaogang Wang

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

sgwangtjm@163.com+86 133 6725 5851

Outcome results

None listed

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