Radical prostatectomy immediately after the diagnosis of prostate cancer by frozen section of targeted biopsy: A Pilot Randomized Controlled Trial

Precision biopsy and novel diagnosis and treatment strategy of prostate cancer based on new imaging technology

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200062557

Enrollment

Unknown

Registered

2022-08-11

Start date

2022-08-08

Completion date

Unknown

Last updated

2023-04-12

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

Conditions

Prostate cancer

Interventions

Control group:Transperineal cognitive fusion targeted and systematic biopsy. According to the pathological diagnosis of biopsy: ? Positive pathology: elective readmission for radical prostatectomy ± p

Test group:Transperineal cognitive fusion targeted biopsy combined with rapid frozen pathological examination. According to the results of rapid pathological diagnosis: ? Patients with positive result

Eligibility

Sex/Gender

Male

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years and = 3 and/or positive PSMA PET/CT); 5. Clinical stage T1-3AN0M0; 6. Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. History of urinary tract infection or acute prostatitis within 3 months; 2. Previous prostate biopsy or other prostate surgery, such as transurethral resection of the prostate; 3. Previous endocrine therapy; 4. Previously received pelvic radiotherapy; 5. Mental illness is unable to understand surgical procedures and sign informed consent; 6. Severe cardiopulmonary and other related diseases, unable to tolerate radical prostatectomy; 7. Other researchers think it is not suitable for inclusion.

Design outcomes

Primary

Measure	Time frame
Biochemical relapse-free survival at 1 year after treatment;	—

Secondary

Measure	Time frame
hospitalization expenses;length of stay;Surgeon's rating of the degree of intraoperative inflammatory adhesion of the prostatic apex;Patient satisfaction;Complications according to Clavien-Dindo classification;The operation time;Estimated blood loss;Positive rate of surgical margin in radical prostatectomy;The accuracy of intraoperative rapid freezing in pathological diagnosis;The coincidence rate of Gleason score between intraoperative rapid freezing pathology and postoperative radical pathology;Risk factors affecting the accuracy of frozen pathology in targeted biopsy;Incidence of urinary incontinence 1 year after operation;	—

Measure

Time frame

hospitalization expenses;length of stay;Surgeon's rating of the degree of intraoperative inflammatory adhesion of the prostatic apex;Patient satisfaction;Complications according to Clavien-Dindo classification;The operation time;Estimated blood loss;Positive rate of surgical margin in radical prostatectomy;The accuracy of intraoperative rapid freezing in pathological diagnosis;The coincidence rate of Gleason score between intraoperative rapid freezing pathology and postoperative radical pathology;Risk factors affecting the accuracy of frozen pathology in targeted biopsy;Incidence of urinary incontinence 1 year after operation;

—

Countries

China

Contacts

Public ContactMing Liu

Beijing Hospital

liumingbjh@126.com+86 1085136272

Outcome results

None listed

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