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

NCT01160705 | Completed

• 3 other identifiers: CTRIAL-IE (ICORG) 08-08ICORG-08-08EU-21044
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Cancer; Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Presence of mRNA in circulating tumor cells as a predictor of response

  ongoing

Secondary Outcomes (1)

• Development of a predictive model

  End of trial

Interventions

docetaxel DRUG

RNA analysis GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

circulating tumor cell analysis OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (5)

Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

Dublin, 24, Ireland

Location

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

St. James's Hospital

Dublin, 8, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

Mater Private Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Prostatic Neoplasms

Interventions

Docetaxel; Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Ray McDermott, MD

  Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 12, 2010
• Study Start: November 1, 2009
• Primary Completion: September 19, 2017
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

IE (5)