Castration-Resistant Prostatic CancerPTtWESNCT04126915
Precise Therapy for mCRPC Patients Through Whole Exome Sequencing(PTtWES)
An observational study of Castration-Resistant Prostatic Cancer, run by Yinghao Sun.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Castration-Resistant Prostatic Cancer
- What is being tested?
- Whole Exome Sequencing
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2019to 8 Oct 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The enrolled patients were mCRPC patients with measurable and retrievable metastases.
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Conditions
- Castration-Resistant Prostatic Cancer
- Being tested
- Whole Exome Sequencing
- Keywords
- Castration-Resistant Prostatic Cancer, Whole Exome Sequencing
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Exome SequencingGenetic
Whole Exome Sequencing of the patient's primary tumor, metastases
What is being measured
The primary outcome is the main question the study is designed to answer.
The genetic characteristics of mCRPC patients in China
The genetic characteristics of mCRPC patients in China as Assessed by Gene Sequencing
Measured: June 2020
Secondary outcomes (2)
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
Measured: 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
Measured: June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start8 Nov 2019 (estimated)
- Primary completion8 Oct 2022 (estimated)
- Study completion8 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-Resistant Prostatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Yinghao Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yinghao Sun, Changhai Hospital
- Investigators
- yinghao sun, PHD, Study chair, Department of Urology，Changhai Hospital of Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126915
- Sponsor's protocol ID
- mCRPC-WES2019
- Acronym
- PTtWES
- Status last verified
- Oct 2019
- First submitted
- 24 Sep 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Therapy for mCRPC Patients Through Whole Exome Sequencing
- ClinicalTrials.gov ID
- NCT04126915
- Acronym / sponsor ID
- PTtWES / mCRPC-WES2019
- Conditions
- Castration-Resistant Prostatic Cancer
- Keywords
- Castration-Resistant Prostatic Cancer, Whole Exome Sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yinghao SunUniversity, hospital or other
- Study start
- 8 Nov 2019 (estimated)
- Primary completion
- 8 Oct 2022 (estimated)
- Study completion
- 8 Oct 2024 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The enrolled patients were mCRPC patients with measurable and retrievable metastases.
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Exome SequencingWhole Exome Sequencing of the patient's primary tumor, metastases | Genetic | – |
Primary outcome
The genetic characteristics of mCRPC patients in China
Time frame: June 2020
The genetic characteristics of mCRPC patients in China as Assessed by Gene Sequencing
2 secondary outcomes
the possible prognostic therapeutic target
Time frame: June 2023
The best method to treat the disease
Time frame: June 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yinghao sun, PHD study chair
Department of Urology，Changhai Hospital of Second Military Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Castration-Resistant Prostatic Cancer, run by Yinghao Sun.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jing li, PHD (+81-15801966205, drlijing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The genetic characteristics of mCRPC patients in China (time frame: June 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.