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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01160705
First received: July 9, 2010
Last updated: August 22, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Presence of mRNA in circulating tumor cells as a predictor of response [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development of a predictive model [ Time Frame: End of trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160705

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      
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
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: August 22, 2014
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014