Study of Blood Samples in Predicting How Patients With Prostate Cancer Will Respond to Treatment With Docetaxel
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Metastatic Cancer Prostate Cancer |
Drug: docetaxel Genetic: RNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: circulating tumor cell analysis Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Biomarkers of Response to Taxotere in Hormone-Refractory Prostate Cancer |
- Presence of mRNA in circulating tumor cells as a predictor of response [ Time Frame: ongoing ] [ Designated as safety issue: No ]
- Development of a predictive model [ Time Frame: End of trial ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Hormone refractory Prostate Cancer patients who are due to receive their first treatment with Docetaxel.
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| Ireland | |
| Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital | Recruiting |
| Dublin, Ireland, 24 | |
| Contact: Contact Person 353-1-414-2012 | |
| Beaumont Hospital | Recruiting |
| Dublin, Ireland, 9 | |
| Contact: Contact Person 353-1-809-2373 | |
| Mater Misericordiae University Hospital | Recruiting |
| Dublin, Ireland, 7 | |
| Contact: Contact Person 353-1-885-8569 | |
| Mater Private Hospital | Recruiting |
| Dublin, Ireland | |
| Contact: Contact Person 01 885 8888 | |
| St. James's Hospital | Recruiting |
| Dublin, Ireland, 8 | |
| Contact: Contact Person 353-1-416-2169 | |
| Principal Investigator: | Ray McDermott, MD | Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICORG- All Ireland Cooperative Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT01160705 History of Changes |
| Other Study ID Numbers: | CDR0000680613, ICORG-08-08, EU-21044 |
| Study First Received: | July 9, 2010 |
| Last Updated: | October 24, 2012 |
| Health Authority: | Ireland: Health Information and Quality Authority |
Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
|
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 |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Prostatic Neoplasms Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013