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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Hongqian Guo; Phone Number: 13605171690 13605171690; Email: dr.ghq@nju.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
      • Contact: Shun Zhang; Phone Number: 15050589789 15050589789; Email: explorershun@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Men diagnosed with non-metastatic prostate cancer

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IUNU-PC-107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No