The role of three-dimensional fusion targeted prostate biopsy for the diagnosis of prostate cancer

An open, randomized, controlled, single-center, prospective three-arm phase II clinical study of three-dimensional fusion targeted prostate biopsy and systemic biopsy in the positive rate of prostate biopsy

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036915

Enrollment

Unknown

Registered

2020-08-25

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-28

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

Conditions

Prostate cancer

Interventions

Three-dimensional fusion targeted biopsy group:MR-PSMA-TRUS Three-dimensional fusion + system puncture

control group:system puncture

Eligibility

Sex/Gender

Male

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Male patients; 2. Age is greater than or equal to 18 years old and less than or equal to 90 years old; 3. Good physical condition, ECOG score 0 or 1; 4. Meet the indications for prostate biopsy: A. Nodules found on digital rectal examination, any PSA value. B. PSA>10ng/ml, any f/t PSA and PSAD value. C. PSA 4-10ng/ml, f/t PSA is abnormal or PSAD value is abnormal. D. PSA 4-10ng/ml, f/t PSA and PSAD values are normal, B-ultrasound finds prostate hypoechoic nodules or/and MRI finds abnormal signals. 5. The patient participates voluntarily and signs an informed consent form; 6. The patient must be able to receive treatment and regular follow-up.

Exclusion criteria

Exclusion criteria: 1. The patient has been diagnosed with prostate cancer (the pathological type is not limited); 2. Although the patient has not undergone prostate biopsy, he has been clinically diagnosed with prostate cancer and has begun to receive relevant treatment; 3. Poor physical condition, unable to withstand prostate biopsy; 4. Combined with history of other malignant tumors; 5. Other serious diseases, including but not limited to: heart disease that is still unstable after treatment, myocardial infarction within 6 months before treatment, heart function 3-4 (NYHA); hypertension that cannot be controlled by medical treatment (Greater than 150/90mmHg), serious neurological or psychological disorders including dementia or epilepsy; uncontrolled active infection; acute gastric ulcer; hypercalcemia; chronic obstructive pulmonary disease requiring hospitalization; 6. Participated in other clinical research before joining the group; 7. Patients who cannot stop anticoagulant drugs.

Design outcomes

Primary

Measure	Time frame
Prostate cancer positive diagnosis rate;	—

Secondary

Measure	Time frame
Incidence of adverse reactions of puncture;	—

Countries

China

Contacts

Public ContactGuoWen Lin

Doctor's Office, 8th Floor, Building 3, Fudan University Shanghai Cancer Hospital

linguowen1024@126.com+86 18017317216

Outcome results

None listed

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