A multi-center, prospective, randomized controlled trial comparing radical prostatectomy with and without prostate biopsy in patients with high-risk prostate cancer assessed by combined imaging

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200058136

Enrollment

Unknown

Registered

2022-03-30

Start date

2022-05-01

Completion date

Unknown

Last updated

2023-12-03

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:Radical prostatectomy without prostate biopsy

Control group:Radical prostatectomy without prostate biopsy

Eligibility

Sex/Gender

Male

Age

40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50-75 years males; 2. PSA>4ng/ml; 3. Prostate multiparametric nuclear magnetic lesion pi-rads score = 4; 4. PSMA PET / CT positive.

Exclusion criteria

Exclusion criteria: 1. Men aged 75 years; 2. History of prostate biopsy; 3. Prostate MRI unavailable; 4. Long term oral medications influence PSA outcomes; 5. Complicated severe urinary tract infection; 6. History of surgical treatment of the prostate; 7. Inability to cooperate with mental abnormalities; 8. Markedly abnormal cardiac, pulmonary, hepatic, and renal function with inadequate compensatory function or the presence of significant systemic disease unable to tolerate surgery.

Design outcomes

Primary

Measure	Time frame
Complication rate;Treatment cost;	—

Secondary

Measure	Time frame
Operative time;Hospital stay;	—

Contacts

Public ContactXing Nianzeng

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

xingnianzeng@hotmail.com+86 18601238866

Outcome results

None listed

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