Prostate Cancer
Conditions
Brief summary
The aim of this study was to investigate the value of dual-parameter magnetic resonance imaging(bpMRI) combined with regional saturation biopsy in the diagnosis of prostate cancer by means of a prospective randomized controlled study. The main questions it aims to answer are: Can bpMRI guide the timing of prostate puncture and avoid unnecessary prostate biopsy? Effectiveness of focal saturation biopsy versus systemic biopsy + targeted biopsy.
Interventions
PROCEDUREFollow up if MRI is negative
Enter the follow-up cohort without systematic biopsy when prostate cancer is clinically suspected and no PIRADS v2.1 score ≥3 lesions are detected on initial examination. MR plus regional saturation biopsy was performed when MRI progressed.
PROCEDURESystematic biopsy if MRI is negative
Systematic biopsy was performed if there was clinical suspicion of prostate cancer and no PIRADS v2.1 score ≥3 lesions were detected on initial examination. If the biopsy was negative enter the follow-up cohort.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be 18 years of age or older. 2. Compliance with clinical guidelines for indications for prostate puncture: * suspicious prostate nodule detected on rectal palpation; * suspicious lesion detected by transrectal ultrasound or magnetic resonance; * tPSA \> 10 ng/mL; * tPSA 4-10 ng/mL with f/t \< 0.16 or PSAD \> 0.15. 3. Complete sequence of bpMRI of the prostate at our institution;
Exclusion criteria
1. tPSA \>50ng/mL; 2. Presence of contraindications to prostate puncture and inability to tolerate prostate puncture; 3. reatment with radiotherapy, chemotherapy and surgery before prostate puncture; 4. History of prostate cancer; 5. Prostate multiparametric magnetic resonance images of poor quality or some sequences are missing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clinically significant prostate cancer (csPCa) detection rate | One month after the biopsy procedure. | csPCa was defined as PCa with a grade group \> 2 or GS ≥ 7. The reference standard was the pathological result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Gleason score (GS) of the biopsy sample | One month after the biopsy procedure. | The Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade. |
| The PCa detection rate | One month after the biopsy procedure. | — |
Countries
China
Outcome results
None listed