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Research of the accuracy of 18F-DCFPyL PET/MR targeted fusion biopsy in prostate cancer diagnosis

Research of the accuracy of 18F-DCFPyL PET/MR targeted fusion biopsy in prostate cancer diagnosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053310
Enrollment
Unknown
Registered
2021-11-18
Start date
2021-12-01
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:18F-DCFPyL PET/MR targeted fusion biopsy
Control group:Systematic biopsy
Surgery without preoperative biopsy group:Radical prostatectomy without preoperative biopsy

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50 to 80 years; 2. Patients examined by 18F-DCFPyL PET/MR with miPSMA >= 2 and PI-RADS >= 4 and will receive biopsy in 3 months after imaging tests; 3. Patients with 4-30 ng/ml tPSA before biopsy; 4. Patinets who agree to receive radical prostatectomy if the biopsy is positive; 5. Patients who understand and voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe diseases that cannot receive biopsy or operation; 2. Patients diagnosed local invasion or distant metastasis; 3. Patients with severe mental diseases that cannot cooperate treatment or research; 4. Patients with previous prostate biopsy; 5. Patients with previous transurethral resection of prostate or pelvic surgery; 6. Patients with previous endocrine therapy before biopsy or anticipated endocrine therapy during research.

Design outcomes

Primary

MeasureTime frame
Cancer detection rate;Incidence of second biopsy;The coincidence rate of postoperative pathology with biopsy pathology;The positive rate of second biopsy;

Secondary

MeasureTime frame
Complication of biopsy rate;

Countries

China

Contacts

Public ContactZhang Xu

Chinese PLA General Hospital

xzhang@foxmail.com+86 13801350955

Outcome results

None listed

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