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A Prospective Clinical Study on the Accuracy of the Mona Lisa Percutaneous Robot for Targeted Biopsy of Prostate Cancer Lesions Smaller than 0.8cm

A Prospective Clinical Study on the Accuracy of the Mona Lisa Percutaneous Robot for Targeted Biopsy of Prostate Cancer Lesions Smaller than 0.8cm

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400080310
Enrollment
Unknown
Registered
2024-01-25
Start date
2024-01-31
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

Prostate Cancer

Interventions

Gold Standard:Pathological diagnosis of tissues obtained through transperineal targeted combined with systematic biopsy procedure
Index test:Accuracy of Pathological Diagnosis Results from Targeted Biopsy Using the Mona Lisa Percutaneous Robot

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 85 years. 2. MRI shows a lesion with a Prostate Imaging Reporting and Data System (PIRADS) score of 3 or higher. 3. Maximum diameter of the lesion on MRI is =0.8cm. 4. PSA (Prostate-Specific Antigen) level is =20ng/mL. 5. Eastern Cooperative Oncology Group (ECOG) performance status score is =2. 6. Signed informed consent and willingness to cooperate with study follow-ups.

Exclusion criteria

Exclusion criteria: 1. Lack of complete MRI data from this center. 2. History of neoadjuvant therapy, including hormonal treatment, radiotherapy, or chemotherapy. 3. History of prior prostate surgery. 4. Overall poor general condition, unable to tolerate biopsy procedures. 5. Absence of anus or congenital absence of the anus following rectal or anal surgery. 6. Other conditions deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
safety;

Countries

China

Contacts

Public ContactLiu Ming

Beijing Hospital

liumingbjh@126.com+86 139 1103 6970

Outcome results

None listed

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