Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15 (ICORG 06-15)
RATIONALE: Studying samples of blood and urine 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 and urine samples in patients with newly diagnosed localized prostate cancer treated with hormone therapy and radiation therapy.
Drug: releasing hormone agonist therapy
Genetic: protein expression analysis
Genetic: proteomic profiling
Other: laboratory biomarker analysis
Radiation: radiation therapy
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer|
- Changes in serum and urine proteomic profiles [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
- Prognostic and biochemical markers of early disease progression [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
- Protein expression and temporal alterations [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
- Molecular targets [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
- Detect changes in serum and urine proteomic profiles that predict outcome in patients with newly diagnosed localized prostate cancer treated with hormonal therapy and radiotherapy.
- Identify prognostic and biochemical markers of early disease progression in patients treated with this regimen.
- Identify unique protein expression and temporal alterations, in these profiles, that facilitate understanding of the factors predicting relapse or toxicity.
- Identify molecular signatures that allow identification of targets for therapeutic intervention.
OUTLINE: This is a multicenter study.
Patients receive induction hormones* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy. Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment.NOTE: * Patients receiving short-term hormonal treatment for 4-8 months are eligible to participate in the trial.
Blood and urine samples are collected at baseline, and periodically during and after induction therapy for proteomic analysis.
After completion of study therapy, patients are followed up periodically for up to 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955435
|UPMC Beacon Hospital|
|Dublin, Ireland, 18|
|Saint Luke's Radiation Oncology Network|
|Dublin, Ireland, 6|
|Principal Investigator:||John Gerard Armstrong, MD, MB, MRCPI||Saint Luke's Hospital|