Prostate Cancer MetastaticNCT03089099
Expression of Molecular Markers in Circulating Tumor Cells of Metastatic Castration-Resistant Prostate Cancer
An observational study of Prostate Cancer Metastatic, run by Fudan University at 1 site in China.
Trial summary
As prostate cancer progresses into castration-resistant stage from initial hormone-sensitive status, the biological behavior of tumor cells that dissociated from primary lesions changed. Considered a "liquid biopsy," these circulating tumor cells (CTCs) can show how a patient's cancer responded to treatments. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- Blood drawing
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2017to Apr 2019
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly Diagnosed High Volume Metastatic Castration-Resistant Prostate Cancer.
Who may be able to join
- Male patients
- 18 yrs and older, and 80 yrs and younger
- Histologically or cytologically proven prostate adenocarcinoma;
- Imaging examinations including Emission Computed Tomography (ECT), Positron Emission Tomography (PET) and so on revealed a high-volume disease of patients(A high-volume of disease was defined by the presence of visceral metastases or four or more bone lesions with at least one beyond the vertebral bodies and pelvis)
- Have been received hormonal therapy and progressed into castration-resistant stage
- Not yet receiving chemotherapy
- Patients are willing to participate and can be followed up regularly
Who cannot join
- Received the treatment of abiraterone acetate previously
- Patients received chemotherapy previously
- Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dai Bo, MD, +86-21 64175590
Dai Bo, MD
About this study
Official title: Development of a Prognostic Model for High Volume Metastatic Castration-Resistant Prostate Cancer Patients by Sequentially Analyzing the Expression of Molecular Markers in Circulating Tumor Cells
As prostate cancer progresses into castration-resistant stage from initial hormone-sensitive status, the biological behavior of tumor cells that dissociated from primary lesions changed. Considered a "liquid biopsy," these circulating tumor cells (CTCs) can show how a patient's cancer responded to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of molecular markers in high volume circulating tumor cells in metastatic castration-resistant prostate cancer patients can predict the therapeutic effects and outcomes of these patients.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- Blood drawing
- Keywords
- Metastatic Castration-Resistant Prostate Cancer, circulating tumor cells, Prognosis, Liquid biopsy
- Medical subject headings
- Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawingOther
Blood drawing
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Overall survival was defined as the period of time from inclusion to death from any cause, or to the last follow up date.
Measured: 2 years
Secondary outcomes (3)
time to prostate specific antigen (PSA) progression
time from inclusion to prostate specific antigen (PSA) progression
Measured: 2 years
time to radiographic progression
time from inclusion to radiographic progression
Measured: 2 years
complete serologic response rate at 3 month and 6 month
prostate specific antigen response rate at 3 month and 6 month
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start24 Apr 2017
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Dai, Fudan University
- Investigators
- Dai Bo, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089099
- Sponsor's protocol ID
- CTC-mCRPC
- Status last verified
- Apr 2017
- First submitted
- 20 Mar 2017
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- 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 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Prognostic Model for High Volume Metastatic Castration-Resistant Prostate Cancer Patients by Sequentially Analyzing the Expression of Molecular Markers in Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT03089099
- Acronym / sponsor ID
- CTC-mCRPC
- Conditions
- Prostate Cancer Metastatic
- Keywords
- Metastatic Castration-Resistant Prostate Cancer, circulating tumor cells, Prognosis, Liquid biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 24 Mar 2017 (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.
As prostate cancer progresses into castration-resistant stage from initial hormone-sensitive status, the biological behavior of tumor cells that dissociated from primary lesions changed. Considered a "liquid biopsy," these circulating tumor cells (CTCs) can show how a patient's cancer responded to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of molecular markers in high volume circulating tumor cells in metastatic castration-resistant prostate cancer patients can predict the therapeutic effects and outcomes of these patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly Diagnosed High Volume Metastatic Castration-Resistant Prostate Cancer.
Key inclusion criteria (7 listed)
- Male patients
- 18 yrs and older, and 80 yrs and younger
- Histologically or cytologically proven prostate adenocarcinoma;
- Imaging examinations including Emission Computed Tomography (ECT), Positron Emission Tomography (PET) and so on revealed a high-volume disease of patients(A high-volume of disease was defined by the presence of visceral metastases or four or more bone lesions with at least one beyond the vertebral bodies and pelvis)
- Have been received hormonal therapy and progressed into castration-resistant stage
Key exclusion criteria (3 listed)
- Received the treatment of abiraterone acetate previously
- Patients received chemotherapy previously
- Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years).
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 |
|---|---|---|
| Blood drawingBlood drawing | Other | – |
Primary outcome
overall survival
Time frame: 2 years
Overall survival was defined as the period of time from inclusion to death from any cause, or to the last follow up date.
3 secondary outcomes
time to prostate specific antigen (PSA) progression
Time frame: 2 years
time to radiographic progression
Time frame: 2 years
complete serologic response rate at 3 month and 6 month
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer Metastatic
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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.
Dai Bo, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Metastatic, run by Fudan University at 1 site in China.
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 7 inclusion and 3 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 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dai Bo, MD (+86-21 64175590, bodai1978@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 2 years). 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 1 May 2017.