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A randomised controlled study of biopsy-free radical prostatectomy based on combined PSMA PET/CT and mpMRI diagnosis in patients with highly suspicious prostate cancer

A randomised controlled study of biopsy-free radical prostatectomy based on combined PSMA PET/CT and mpMRI diagnosis in patients with highly suspicious prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095102
Enrollment
Unknown
Registered
2025-01-02
Start date
2025-01-06
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Prostate cancer

Interventions

Control group:Transperineal prostate biopsy+Robotic radical prostatectomy
Experimental group:Robotic radical prostatectomy

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 60-80 years old; 2.Blood PSA 4-20 ng/ml; 3.miPSMA >= 2 and PI-RADS>=4 by PSMA PET/MRI, and the time of surgery was within 3 months after the imaging examination; 4. Pre-operative imaging stage was earlier than cT3b and there was no pelvic lymph node metastasis and distant metastasis; 5. Agreed to enter this study for surgical treatment and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Presence of severe underlying diseases that cannot tolerate puncture or surgery; 2.Patients found to have local invasion or distant metastasis; 3.Presence of severe mental disorders that cannot cooperate with the treatment or study; 4.Patients with previous prostate puncture; 5.Patients with previous transurethral prostate electrocision and pelvic surgery; 6.Patients with previous or expected endocrine therapy prior to surgical treatment.

Design outcomes

Primary

MeasureTime frame
Patient-based detection rate of csPCa;Lesions-based detection rate of csPCa;

Secondary

MeasureTime frame
Major tumour localisation rate;Positive surgical margins;PSA levels 6 weeks after surgery;

Countries

China

Contacts

Public ContactWang Baojun

Chinese PLA General Hospital

baojun40009@126.com+86 135 2190 8910

Outcome results

None listed

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