Prostate CancerNCT02723526
Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer
An observational study of Prostate Cancer, run by Fudan University at 1 site in China.
Trial summary
As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds 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
- What is being tested?
- Blood drawing
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 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 Metastatic Hormone-Sensitive 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),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis;
- Not yet receiving hormonal therapy;
- Not yet receiving chemotherapy previously;
- Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
- Patients are willing to participate and can be followed up regularly；
Who cannot join
- Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
- Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion;
- 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
Bo Dai, MD, +86-21 64175590, bodai1978@163.com
About this study
Official title: Development of a Prognostic Model for Metastatic Hormone-sensitive Prostate Cancer by Sequentially Analyzing the Expression of Tumor Markers in Circulating Tumor Cells
As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.
- Conditions
- Prostate Cancer
- Being tested
- Blood drawing
- Keywords
- Metastatic Hormone-Sensitive Prostate Cancer；circulating tumor cells；Prognosis；Liquid biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawingOther
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Not described Receives: Other: Blood drawing |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to castration-resistant prostate cancer
Measured: 3 years
Secondary outcomes (4)
time to radiographic progression
Measured: 3 years
time to prostate specific antigen (PSA) progression
Measured: 3 years
time to prostate specific antigen (PSA) nadir
Measured: 2 years
complete serologic response rate at 6 month and 12 month
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- 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
- Bo Dai, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723526
- Sponsor's protocol ID
- CTC-mHSPC
- Status last verified
- Mar 2016
- First submitted
- 26 Mar 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Prognostic Model for Metastatic Hormone-sensitive Prostate Cancer by Sequentially Analyzing the Expression of Tumor Markers in Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT02723526
- Acronym / sponsor ID
- CTC-mHSPC
- Conditions
- Prostate Cancer
- Keywords
- Metastatic Hormone-Sensitive 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
- Mar 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 30 Mar 2016 (estimated)
- 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, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Other: Blood drawing |
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 Metastatic Hormone-Sensitive Prostate Cancer
Key inclusion criteria (8 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),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis;
- Not yet receiving hormonal therapy;
Key exclusion criteria (4 listed)
- Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
- Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion;
- 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 drawing | Other | Single arm |
Primary outcome
time to castration-resistant prostate cancer
Time frame: 3 years
4 secondary outcomes
time to radiographic progression
Time frame: 3 years
time to prostate specific antigen (PSA) progression
Time frame: 3 years
time to prostate specific antigen (PSA) nadir
Time frame: 2 years
complete serologic response rate at 6 month and 12 month
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- 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.
Bo Dai, 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, 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 8 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 31 Mar 2016. 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 Bo Dai, 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?
time to castration-resistant prostate cancer (time frame: 3 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 31 Mar 2016.