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Multi-center prospective clinical study of prostate cancer antigen (PCA3) combined with fusion gene detection used in the diagnosis and risk stratification prediction of prostate cancer

Multi-center prospective clinical study of prostate cancer antigen (PCA3) combined with fusion gene detection used in the diagnosis and risk stratification prediction of prostate cance

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDD-17012321
Enrollment
Unknown
Registered
2017-08-10
Start date
2017-08-02
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

Prostate Cancer

Interventions

Sponsors

Department of Urology, Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: Part 1: One of the following cases occurs in men age over 40: 1. Symptoms: repeated macroscopic hematuria, difficulty in urination, etc. 2. Sign: suspected nodules detected by the prostate digital rectal examination(DRE). 3. PSA: PSA value more than 3 ng/ml, fPSA/tPSA value less than 0.16. 4. Transrectal ultrasonography(TRUS): an internal structural disturbance or low echo area in the prostate. 5. Willing to accept research and sign research voluntary books. Part 2: Case inclusion criteria (based on EUA prostate cancer treatment guidelines 2016) : 1. Patients with low-risk prostate cancer (T1b - T2c, N0, M0), and life expectancy was greater than 10 years. 2. Patients with high risk of prostate cancer (T3a, N0, M0), and life expectancy is greater than 10 years. 3. Patients with locally advanced high risk of prostate cancer (cT3b–T4, N0 or any T, N1, M0), and life expectancy is greater than 10 years. 4. The tumor staging was lower than T1a, but patients had a strong desire to operate and the life expectancy expected to live longer. 5. Willing to accept research and sign research voluntary books.

Exclusion criteria

Exclusion criteria: Part 1: ? Acute urinary tract infection and intestinal infection. ? Recent factors such as urinary catheterizing, bladder microscopy or prostate massage which have affected the elevated PSA. ? Refuse to follow up. Part 2: ? The previous history of bladder neck, urethra, and pelvic surgery. ? Accompany with severe blood coagulation dysfunction, difficult to control high blood pressure or diabetes, severe heart, lung, liver, kidney and other important organ dysfunction, or other serious internal medical disease, or life expectancy less than 10 years. ? Accompany with other tumors, oral immune inhibitors, and blood disease. ? Unwilling to participate in the research or the follow-up address is unclear.

Design outcomes

Primary

MeasureTime frame
PCA3 fusion gene;PSA;TRUS;MR;B-ultrasonography;Gleason score;

Countries

China

Contacts

Public ContactQiu Jianguang

Department of Urology, Third Affiliated Hospital of Sun Yat-sen University

qjg_zssy@126.com+86 18988922990

Outcome results

None listed

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