Prostate Cancer
Conditions
Brief summary
The study aims to investigate the incidence of prostate cancer among males in Nanjing and whether a combination of PSA, multi-parametric MRI and targeted biopsy is a feasible approach for screening prostate cancer in China.
Detailed description
The investigators are going to collect serum samples and clinical information from men aged ≥50 years taking physical examination in community health service centers in Nanjing. The investigators will propose mpMRI for those with serum PSA ≥4 ng/mL. Transperineal systematic biopsy (TPSB) combined with MRI /ultrasound fusion targeted biopsy (TB) will be offered for those scored ≥3 on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). TPSB alone will be offered for those scored \<3 and serum PSA ≥10 ng/mL. Subjects with serum PSA between 4 ng/mL and 10 ng/mL and PI-RADS score \<3 points will be referred to follow-up examinations every 6 months.
Interventions
DIAGNOSTIC_TESTmulti-parametric MRI
Multi-parametric MRI will be suggested for those PSA ≥4 ng/mL, PI-RADS v2 score will be used to evaluate images.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 50 * (Eastern Cooperative Oncology Group)ECOG grade: 0-1 * Normal organic function indexes: * (absolute neutrophil count)ANC ≧1.5×109/L * (platelet count)PLT ≧100×109/L * Hb ≧90 g/L * (total bilirubin)TBIL ≦1.5×ULN * (aspartate aminotransferase)ALT≦2.5×ULN * (alanine aminotransferase)AST ≦2.5×ULN * (blood urea nitrogen)BUN (orUREA) and Cr ≦1.5×ULN
Exclusion criteria
* Former serum PSA detection * Having took Proscar in the past 3 months * Suffered from any other malignant tumor in the past 5 years * History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system * Having took Proscar in the past 3 months * Suffered from any other malignant tumor in the past 5 years * History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of prostate cancer | 3 years | Incidence of prostate cancer among males ≥50 years old |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with different gleason scores | 3 years | Gleason score of prostate cancer patients, Including 7 degrees:3+3=6,3+4=7,4+3=7,4+4=8,4+5=9,5+4=9,5+5=10. |
| Number of participants with different clinical stages | 3 years | Clinical stage of prostate cancer patients according to the eighth version of American Joint Committee on Cancer(AJCC) guideline for prostate cancer. |
| Number of participants with different risk groups | 3 years | Devided to three risk groups(high-medium-low) according to D'Amico risk groups of prostate cancer. |
| Number of participants with different prognostic stage groups | 3 years | Prognostic stage of prostate cancer patients according to the eighth version of American Joint Committee on Cancer(AJCC) guideline for prostate cancer. |
Countries
China
Contacts
Primary ContactXiaozhi Zhao
Backup ContactHongqian Guo
Outcome results
None listed