Metastatic CancerNCT01160705
Biomarkers of Response to Taxotere in HRPC. ICORG 08-08, V2
An observational study of Metastatic Cancer and Prostate Cancer, run by Cancer Trials Ireland at 5 sites in Ireland.
Trial summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Cancer, Prostate Cancer
- What is being tested?
- docetaxel, RNA analysis and reverse transcriptase-polymerase chain reaction
- How many people
- 73 participants
- Where
- 5 sitesIreland
- Study dates
- Nov 2009to 19 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: Hormone refractory Prostate Cancer patients who are due to receive their first treatment with Docetaxel.
Who may be able to join
- Patients must satisfy the following criteria:
- Patients must, in the opinion of the Investigator, be suitable for treatment with Docetaxel on a weekly, biweekly or three weekly schedule.
- Patients must be aged 18 years or over.
- Patients must have histologically or cytologically proven adenocarcinoma of the prostate gland.
- Patients must have evidence of locally advanced or metastatic disease (e.g. bone, pelvic mass, lymph node, liver or lung metastases).
- Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (LHRH-agonist etc.) with evidence of treatment failure.
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- Patients must not have received prior treatment with chemotherapy.
- Patients must be able to give written informed consent.
- Prior radiotherapy is allowed.
- Concomitant use of bisphosphonates is allowed.
Who cannot join
- Patients who have received previous cytotoxic therapy for prostate cancer are ineligible.
- Patients who in the judgement of their treating physician will not be able to receive therapy and follow-up according to the protocol guidelines will be ineligible.
- Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
- History of other primary cancer, unless:
- Curatively resected non-melanomatous skin cancer
- Other primary solid tumour curatively treated with no known active disease present and no curative treatment for the last year.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ireland5 sites
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, 24
Mater Misericordiae University Hospital
Dublin, 7
St. James's Hospital
Dublin, 8
Beaumont Hospital
Dublin, 9
Mater Private Hospital
Dublin
About this study
Official title: Biomarkers of Response to Taxotere in Hormone-Refractory Prostate Cancer
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying blood samples in predicting how patients with prostate cancer will respond to treatment with docetaxel.
Read the detailed description
OBJECTIVES:
Primary
- To determine if mRNA present in circulating tumor cells will help predict response in patients with hormone-refractory prostate cancer treated with docetaxel.
- In parallel with this, based on discoveries made since our protocol was initially submitted to ICORG, here we also propose to analyse serum specimens from these consenting patients for the presence of EC miRNA, mRNA and protein predictive of response to Taxotere.
Secondary
- To develop a predictive model based on the most accurate and sensitive combination of these biomarkers.
OUTLINE: This is a multicenter study.
Treatment Plan:
All patients will be treated with Docetaxel on a weekly, biweekly or three weekly schedule, dose and schedule at the discretion of the treating physician.
Blood samples are collected for biomarker laboratory studies at baseline, every 3-4 weeks during study, and at disease progression or every 12 weeks after completion of study. Samples are analyzed for mRNA via RT-PCR.
- Conditions
- Metastatic Cancer, Prostate Cancer
- Being tested
- docetaxel, RNA analysis, reverse transcriptase-polymerase chain reaction, circulating tumor cell analysis, laboratory biomarker analysis
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, bone metastases, liver metastases, lung metastases, hormone-resistant prostate cancer
- Medical subject headings
- Neoplasm Metastasis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
RNA analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
circulating tumor cell analysisOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of mRNA in circulating tumor cells as a predictor of response
Measured: ongoing
Secondary outcomes (1)
Development of a predictive model
Measured: End of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startNov 2009
- Primary completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ray McDermott, MD, Principal investigator, Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160705
- Sponsor's protocol ID
- CTRIAL-IE (ICORG) 08-08
- Other IDs
- ICORG-08-08, EU-21044
- Status last verified
- Nov 2020
- First submitted
- 9 Jul 2010
- Last updated
- 17 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Response to Taxotere in Hormone-Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT01160705
- Acronym / sponsor ID
- CTRIAL-IE (ICORG) 08-08
- Conditions
- Metastatic Cancer, Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, bone metastases, liver metastases, lung metastases, hormone-resistant prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Nov 2009
- Primary completion
- 19 Sep 2017 (actual)
- First posted
- 12 Jul 2010 (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.
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying blood samples in predicting how patients with prostate cancer will respond to treatment with docetaxel.
Detailed description
OBJECTIVES:
Primary
- To determine if mRNA present in circulating tumor cells will help predict response in patients with hormone-refractory prostate cancer treated with docetaxel.
- In parallel with this, based on discoveries made since our protocol was initially submitted to ICORG, here we also propose to analyse serum specimens from these consenting patients for the presence of EC miRNA, mRNA and protein predictive of response to Taxotere.
Secondary
- To develop a predictive model based on the most accurate and sensitive combination of these biomarkers.
OUTLINE: This is a multicenter study.
Treatment Plan:
All patients will be treated with Docetaxel on a weekly, biweekly or three weekly schedule, dose and schedule at the discretion of the treating physician.
Blood samples are collected for biomarker laboratory studies at baseline, every 3-4 weeks during study, and at disease progression or every 12 weeks after completion of study. Samples are analyzed for mRNA via RT-PCR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hormone refractory Prostate Cancer patients who are due to receive their first treatment with Docetaxel.
Key inclusion criteria (10 listed)
- Patients must, in the opinion of the Investigator, be suitable for treatment with Docetaxel on a weekly, biweekly or three weekly schedule.
- Patients must be aged 18 years or over.
- Patients must have histologically or cytologically proven adenocarcinoma of the prostate gland.
- Patients must have evidence of locally advanced or metastatic disease (e.g. bone, pelvic mass, lymph node, liver or lung metastases).
- Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (LHRH-agonist etc.) with evidence of treatment failure.
Key exclusion criteria (6 listed)
- Patients who have received previous cytotoxic therapy for prostate cancer are ineligible.
- Patients who in the judgement of their treating physician will not be able to receive therapy and follow-up according to the protocol guidelines will be ineligible.
- Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
- History of other primary cancer, unless:
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 |
|---|---|---|
| docetaxel | Drug | – |
| RNA analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| circulating tumor cell analysis | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Presence of mRNA in circulating tumor cells as a predictor of response
Time frame: ongoing
1 secondary outcome
Development of a predictive model
Time frame: End of trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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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.
Ray McDermott, MD principal investigator
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Prostate Cancer, run by Cancer Trials Ireland at 5 sites in Ireland.
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 10 inclusion and 6 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: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of mRNA in circulating tumor cells as a predictor of response (time frame: ongoing). 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 17 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.