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

NCT05248282 | Unknown DMC

• 1 other identifier: IUNU-PC-107
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• metastasis-free survival

  up to 36 months

• Prognostic value of the three gene-signature in P-score

  up to 36 months

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men diagnosed with non-metastatic prostate cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Hongqian Guo

CONTACT

13605171690; dr.ghq@nju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urology Department

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: September 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

CN (1)