Clinical Validation of the Prognostic Value of the PrTS on Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

A Single-Center, Retrospective, Blinded Validation Study to Investigate the Prognostic Value of the Prostatype Test System (PrTS) in Prostate Cancer Patients in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248282
• Other study ID #: IUNU-PC-107
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Hongqian Guo
• Phone: 13605171690
• Email: dr.ghq[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prostate Cancer is the most common type of cancer among men in many countries. However current clinical tools have limited prediction accuracy to choose the optimal treatment for the individual patient, as prostate cancer risk assessment is a critical aspect of treatment decision-making. A substantial proportion of patients are undergoing over-treatment such as radical treatment, which is often associated with negative physical and psychological side effects, dramatically affecting quality of life in a negative way. Moreover, the patients that are under-treated will face higher cancer mortality risks, which brings more concerns for patients and doctors. Prostatype composes a one-step 4-plex quantitative reverse transcription polymerase chain reaction kit, a database based on authenic patients information and a score system (P-score), intended to measure gene expression levels of three biomarkers: IGFBP3, F3 and VGLL3. Genetic values combined with clinical parameters in the CPMA and P-score are aiming to estimate the aggressiveness of prostate tumor for a newly diagnosed prostate cancer patient. This is a single-center, retrospective, blinded validation study aim to investigate the prognostic performance of the Prostatype test system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria:

• Non-metastatic prostate adenocarcinoma confirmed by histopathology after taking core needle biopsy
• Regular visits, treatment and laboratory tests were conducted in the past
• There is biopsy materials at the time of diagnosis (without staining FFPE)
• The total area of tumor tissue shall be 25-30 mm2, and the proportion of tumor cells after tumor cell enrichment is at least 50%
• Complete records of relevant clinical follow-up information

Exclusion Criteria:

• Biopsy tissue is not available, or FFPE does not meet the screening requirements of study samples
• Relevent clinical parameters of the patients are not available
• Treatment methods are not available
• Age of diagnosis < 50 years
• Age of diagnosis > 100 years
• Total tumor length < 2 mm
• The patient died of an accident, homicide or suicide

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
China	Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	GloriousMed Clinical Laboratory (Shanghai) Co., Ltd., Prostatype Genomics AB

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prostate cancer-specific mortality	To verify that the prediction performance of risk stratification model (P-score) in the Chinese population is superior to that of the current European Society of Urology (EAU) risk stratification standard with regard to prostate cancer-specific mortality	up to 36 months
Secondary	metastasis-free survival	To investigate that the prediction performance of risk stratification model (P-score) in the Chinese population is superior to that of the current European Society of Urology (EAU) risk stratification standard with regard to metastasis free survival	up to 36 months
Secondary	Prognostic value of the three gene-signature in P-score	To verify the prognostic value of the three gene-signature (IGFBP3, F3 and VGLL3) in Chinese population, explore their association with prostate cancer-specific mortality and metastasis free survival	up to 36 months