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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Trials Ireland
• Treatments: 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.