Precise Therapy for mCRPC Patients Through Whole Exome Sequencing(PTtWES) (PTtWES)

Precise Therapy for mCRPC Patients Through Whole Exome Sequencing

Through gene sequencing of the patient's tissue, to figure out the genomic characteristics of patients with advanced disease and guide the treatment of patients

Study Overview

• Status: Not yet recruiting
• Conditions: Castration-Resistant Prostatic Cancer
• Intervention / Treatment: Genetic: Whole Exome Sequencing

Detailed Description

Tumor heterogeneity and tumor clonal evolution cause he diagnosis and treatment difficulties of advanced prostate cancer. Heterogeneity exists in different lesions at the same location of the same tumor, between lesions at different locations, and in the same lesion in different processes of disease progression. Tumor heterogeneity causes different tumor patients to respond differently to different treatments; as patients progress, tumor patients gradually develop clonal evolution, and the original effective treatment will lose the therapeutic effect. And routine imaging examinations and PSA examinations are also difficult to respond to changes in the patient's condition in a timely manner. By Genetic testing of the primary tumor, metastases or blood of the patient, and according to the test result of the patient, the patient's medication treatment can be provided, and the patient's condition change can be monitored. Studies have shown that patients with different mutation types respond differently to the same treatment. Prostate cancer patients with AR-V7 mutations have a poorer response to abiraterone or dextrozamide than patients with prostate cancer without AR-V7 mutation; whereas for solid tumors with MSI-H or dMMR, PD-1 Inhibitors can also bring the desired results to such patients. Therefore, according to the genetic test results of the patient's tumor tissue, early diagnosis can also be given, and the patient's condition change and precise treatment can be predicted.In this study, the investigators hope to obtain the genome characteristics of advanced patients by performing whole exon sequencing on the patient's tissues, and to guide the patients' follow-up treatment through sequencing results, to observe the effects of different treatment methods on patients and find biomarker that predict patient prognosis

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: jing li, PHD; Phone Number: +81-15801966205; Email: drlijing@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The enrolled patients were mCRPC patients with measurable and retrievable metastases.

Description

Inclusion Criteria:

• Expected survival period ≥ half a year;
• Whole body bone scan (ECT) and magnetic resonance imaging (MRI) or PET-CT are evaluated as metastatic castration to resist prostate cancer patients;
• Patients with evaluable and retrievable lesions;
• Patients who voluntarily receive the experimental study protocol after informing the existing treatment plan;

Exclusion Criteria:

• Patients with other malignancies, or in acute infection or other severe infections; immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or syphilis-positive patients;
• Patients who have long-term anticoagulant and anti-platelet aggregation drugs (the anticoagulant is discontinued for less than 1 week);
• At the same time suffering from other serious systemic diseases, the researchers believe that it may interfere with the treatment, evaluation and compliance of this test, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary and other systems. disease;
• The patient that it is inappropriate to participate in this clinical trial

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The genetic characteristics of mCRPC patients in China	The genetic characteristics of mCRPC patients in China as Assessed by Gene Sequencing	June 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the possible prognostic therapeutic target	the possible prognostic therapeutic target as Assessed by Gene Sequencing ，by observing the patient's prognosis，including PSA progression and progression in imaging by RECIST Version 1.1	June 2023
The best method to treat the disease	Compare the effects of different treatments on the prognosis of patients as Assessed by PSA progression and progression in imaging by RECIST Version 1.1	June 2023

Collaborators and Investigators

• Sponsor: Yinghao Sun
• Investigators: Study Chair: yinghao sun, PHD, Department of Urology，Changhai Hospital of Second Military Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 8, 2019
• Primary Completion (Anticipated): October 8, 2022
• Study Completion (Anticipated): October 8, 2024

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: October 13, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Whole Exome Sequencing; Castration-Resistant Prostatic Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant
• Other Study ID Numbers: mCRPC-WES2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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