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Status unknownNCT05248282Updated Feb 21, 2022

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

An observational study in Prostate Cancer, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Status unknown at 1 site in China. Open to male participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-02-21.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
50 Years to 100 Years
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Men diagnosed with non-metastatic prostate cancer

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No
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What researchers measure

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

    Time frame: up to 36 months

Secondary outcomes

  1. 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

    Time frame: up to 36 months

  2. 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

    Time frame: up to 36 months

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Study locations

1 of 1 sites recruiting
  • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
    Nanjing, Jiangsu 210000, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05248282
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
Prostatype Genomics AB, GloriousMed Clinical Laboratory (Shanghai) Co., Ltd.
Responsible party
Hongqian Guo (Director of Urology Department, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Feb 21, 2022
Start date
Sep 1, 2021
Primary completion
Apr 30, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Feb 21, 2022

Study contacts

Hongqian Guo
Contact
dr.ghq@nju.edu.cn
13605171690 ext. 13605171690

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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