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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Metastatic Cancer
• Intervention / Treatment: Drug: docetaxel; Other: laboratory biomarker analysis; Genetic: RNA analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: circulating tumor cell analysis

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 Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 9
    • Beaumont Hospital
  • Dublin, Ireland, 7
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, 24
    • Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
  • Dublin, Ireland, 8
    • St. James's Hospital
  • Dublin, Ireland
    • Mater Private Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Hormone refractory Prostate Cancer patients who are due to receive their first treatment with Docetaxel.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of mRNA in circulating tumor cells as a predictor of response	ongoing

Secondary Outcome Measures

Outcome Measure	Time Frame
Development of a predictive model	End of trial

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland
• Investigators: Principal Investigator: Ray McDermott, MD, Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): September 19, 2017

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: July 9, 2010
• First Posted (Estimate): July 12, 2010

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: stage III prostate cancer; stage IV prostate cancer; recurrent prostate cancer; bone metastases; adenocarcinoma of the prostate; liver metastases; hormone-resistant prostate cancer; lung metastases
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: CTRIAL-IE (ICORG) 08-08; ICORG-08-08; EU-21044