Metastatic Prostate Cancer, CTCVPCA-B+PIVNCT02742259
Validation of the Prostate Cancer Assay - Beta+Pivotal
An observational study of Metastatic Prostate Cancer, CTC, run by Celsee Diagnostics.
Trial summary
The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC) analysis system will be validated in patients diagnosed with metastatic prostate cancer. It will demonstrate substantial performance equivalency to a CTC Assay predicate device. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer, CTC
- What is being tested?
- Blood Draw
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Sep 2017
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males 18 years and above; Metastatic prostate cancer to the bone as documented by positive bone scan imaging
Who may be able to join
- • Male aged 18 years and above
- Be willing to sign an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
- Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
- Eastern cooperative group (ECOG) performance status ≤2
- Documented histologically confirmed adenocarcinoma of the prostate
- Metastatic prostate cancer to the bone as documented by positive bone scan imaging
- CRPC patient being considered for systemic therapy or in between lines of therapies (>= 14 days from prior treatment) for metastatic disease. Patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group 2 [PCWG2] criteria) and a castrate serum testosterone level (i.e. ≤ 50 mg/dl).
Who cannot join
- • Subjects actively receiving systemic therapy regimens, or between lines of therapies (< 14 days from prior treatment)
- Have any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements
- Active infection or other medical condition that would make corticosteroids (i.e. prednisone) use contraindicated
- Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by antihypertensive treatment
- Severe hepatic impairment (Child-Pugh Class C)
- History of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study)
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- Have poorly controlled diabetes (HgB A1C ≥ 8%)
- Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
- Abnormal bone marrow function (absolute neutrophil count [ANC] < 1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL)
- Abnormal liver function (bilirubin > upper limit of normal [ULN]; AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN)
- Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, unstable atrial fibrillation, or New York Heart Association (NYHA) Class III-IV heart disease
- History of ventricular tachyarrhythmia within the past 5 years
About this study
Official title: Prospective, Multi-Center Validation of the Prostate Cancer Assay
The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC) analysis system will be validated in patients diagnosed with metastatic prostate cancer. It will demonstrate substantial performance equivalency to a CTC Assay predicate device.
- Conditions
- Metastatic Prostate Cancer, CTC
- Being tested
- Blood Draw
- Medical subject headings
- Prostatic Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawDevice
Blood draws only - non-diagnostic, non-treatment
| Study group | Role | What they receive |
|---|---|---|
| Beta Cutoff | Assay Receives: Device: Blood Draw | |
| Pivotal | Assay Receives: Device: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of the clinical utility of the cutoff level for the Prostate Cancer Assay for prognosis of progression free survival (PFS) in comparison to the predicate device, CellSearch CTC Assay
"CTC negative" means a level of CTCs below the cutoff indicating lower risk for progression (i.e. PFS, and "CTC positive" means a level of CTCs at or above the cutoff indicating higher risk for progression (i.e. shorter PFS).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startMay 2016 (estimated)
- Primary completionApr 2017 (estimated)
- Study completionSep 2017 (estimated)
Why it stopped: No enrolled participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate Cancer, CTCStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celsee Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yixin Wang, Ph.D., Study director, Celsee Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742259
- Sponsor's protocol ID
- Celsee CA1001.v1
- Acronym
- VPCA-B+PIV
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2016
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Validation of the Prostate Cancer Assay
- ClinicalTrials.gov ID
- NCT02742259
- Acronym / sponsor ID
- VPCA-B+PIV / Celsee CA1001.v1
- Conditions
- Metastatic Prostate Cancer, CTC
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No enrolled participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Celsee DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- May 2016 (estimated)
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 19 Apr 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.
The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC) analysis system will be validated in patients diagnosed with metastatic prostate cancer. It will demonstrate substantial performance equivalency to a CTC Assay predicate device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta Cutoff | – | Device: Blood DrawAssay |
| Pivotal | – | Device: Blood DrawAssay |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males 18 years and above; Metastatic prostate cancer to the bone as documented by positive bone scan imaging
Key inclusion criteria (7 listed)
- • Male aged 18 years and above
Key exclusion criteria (13 listed)
- • Subjects actively receiving systemic therapy regimens, or between lines of therapies (< 14 days from prior treatment)
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 DrawBlood draws only - non-diagnostic, non-treatment | Device | Beta Cutoff, Pivotal |
Primary outcome
Confirmation of the clinical utility of the cutoff level for the Prostate Cancer Assay for prognosis of progression free survival (PFS) in comparison to the predicate device, CellSearch CTC Assay
Time frame: 9 months
"CTC negative" means a level of CTCs below the cutoff indicating lower risk for progression (i.e. PFS, and "CTC positive" means a level of CTCs at or above the cutoff indicating higher risk for progression (i.e. shorter PFS).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 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.
Yixin Wang, Ph.D. study director
Celsee Diagnostics
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Prostate Cancer, CTC, run by Celsee Diagnostics.
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 13 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: withdrawn, as of the sponsor's last update on 26 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmation of the clinical utility of the cutoff level for the Prostate Cancer Assay for prognosis of progression free survival (PFS) in comparison to the predicate device, CellSearch CTC Assay (time frame: 9 months). 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 26 Mar 2019.