Clinical trial NCT05248282: Clinical Validation of the Prognostic Value of the PrTS on Prostate Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Prostatype Genomics AB
name: GloriousMed Clinical Laboratory (Shanghai) Co., Ltd.
First posted: 2022-02-21
Enrollment: 150
Sex: MALE
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men diagnosed with non-metastatic prostate cancer

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.


Eligibility criteria: 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

Primary outcomes:
measure: prostate cancer-specific mortality
timeFrame: up to 36 months
Secondary outcomes:
measure: metastasis-free survival
timeFrame: up to 36 months
measure: Prognostic value of the three gene-signature in P-score
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
state: Jiangsu
Study officials:
References: