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Biomarkers of Response to Taxotere in HRPC. ICORG 08-08, V2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01160705
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : November 17, 2020
Information provided by (Responsible Party):
Cancer Trials Ireland

Brief 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.

PURPOSE: This clinical trial is studying blood samples in predicting how patients with prostate cancer will respond to treatment with docetaxel.

Condition or disease Intervention/treatment
Metastatic Cancer Prostate Cancer Drug: docetaxel Genetic: RNA analysis Genetic: reverse transcriptase-polymerase chain reaction Other: circulating tumor cell analysis Other: laboratory biomarker analysis

Detailed Description:



  • 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.


  • 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.

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Study Type : Observational
Actual Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Response to Taxotere in Hormone-Refractory Prostate Cancer
Study Start Date : November 2009
Actual Primary Completion Date : September 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

Primary Outcome Measures :
  1. Presence of mRNA in circulating tumor cells as a predictor of response [ Time Frame: ongoing ]

Secondary Outcome Measures :
  1. Development of a predictive model [ Time Frame: End of trial ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hormone refractory Prostate Cancer patients who are due to receive their first treatment with Docetaxel.

Inclusion Criteria:

Patients must satisfy the following criteria:

  1. Patients must, in the opinion of the Investigator, be suitable for treatment with Docetaxel on a weekly, biweekly or three weekly schedule.
  2. Patients must be aged 18 years or over.
  3. Patients must have histologically or cytologically proven adenocarcinoma of the prostate gland.
  4. Patients must have evidence of locally advanced or metastatic disease (e.g. bone, pelvic mass, lymph node, liver or lung metastases).
  5. Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (LHRH-agonist etc.) with evidence of treatment failure.
  6. Patients must not have received prior treatment with chemotherapy.
  7. Patients must be able to give written informed consent.
  8. Prior radiotherapy is allowed.
  9. Concomitant use of bisphosphonates is allowed.

Exclusion Criteria:

  1. Patients who have received previous cytotoxic therapy for prostate cancer are ineligible.
  2. 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.
  3. 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.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01160705

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Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland, 24
Mater Misericordiae University Hospital
Dublin, Ireland, 7
St. James's Hospital
Dublin, Ireland, 8
Beaumont Hospital
Dublin, Ireland, 9
Mater Private Hospital
Dublin, Ireland
Sponsors and Collaborators
Cancer Trials Ireland
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Principal Investigator: Ray McDermott, MD Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
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Responsible Party: Cancer Trials Ireland Identifier: NCT01160705    
Other Study ID Numbers: CTRIAL-IE (ICORG) 08-08
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Keywords provided by Cancer Trials Ireland:
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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action