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Head-to-Head Comparison of Transrectal Ultrasound-Guided Prostate Biopsy With and Without PSMA-PET–Targeted Prostate Biopsy in Biopsy-Naïve Men with Suspected Prostate Cancer: A Prospective, Randomized, Multicenter Study

Head-to-Head Comparison of Transrectal Ultrasound-Guided Prostate Biopsy With and Without PSMA-PET–Targeted Prostate Biopsy in Biopsy-Naïve Men with Suspected Prostate Cancer: A Prospective, Randomized, Multicenter Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093709
Enrollment
Unknown
Registered
2024-12-10
Start date
2021-10-08
Completion date
Unknown
Last updated
2024-12-16

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 :Traditional prostate biopsy (systematic biopsy) and PSMA-TB
Control Group:Only underwent prostate systematic biopsy (TRUS-GB)

Sponsors

Xijing Hospital, Airforce Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Blood prostate-specific antigen PSA>4ng/dl; (2) Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging, and PSMA PET/CT examination. (3) The patient is willing to undergo prostate biopsy.

Exclusion criteria

Exclusion criteria: (1) Previous diagnosis of prostate cancer through prostate biopsy; (2) PSMA PET/CT patients with a PRIMAY score of 1; (3) History of other malignant tumors in the past two years; (4) According to the research physician's judgment, serious complications may occur and affect the normal conduct of the experiment

Design outcomes

Primary

MeasureTime frame
Comparison of the diagnostic efficacy of prostate biopsy combined with PSMA PET/CT targeted biopsy and traditional prostate biopsy alone for clinically significant prostate cancer (csPCa, GG>= 2) in suspected prostate cancer patients;—

Secondary

MeasureTime frame
Compare the diagnostic efficacy of two puncture methods for non clinically significant prostate cancer (GG1) and high-risk prostate cancer (GG >= 3) patients;Comparing the diagnostic efficacy of traditional prostate biopsy and PSMA PET/CT targeted biopsy in the joint group for prostate cancer;Analyze possible improved prostate puncture methods;—

Countries

China

Contacts

Public ContactQin Weijun

Xijing Hospital, Airforce Medical University, PLA

qinweij@fmmu.edu.cn+86 84775321

Outcome results

None listed

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