Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15
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|ClinicalTrials.gov Identifier: NCT00955435|
Recruitment Status : Active, not recruiting
First Posted : August 10, 2009
Last Update Posted : February 18, 2021
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: Non-interventional Genetic: Protein expression analysis Genetic: Proteomic profiling Other: Laboratory biomarker analysis|
- 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 (per standard treatment). 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 5 years and yearly thereafter for the duration of the trial.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer|
|Actual Study Start Date :||February 2006|
- Other: Non-interventional
Patients receive induction hormones* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy per standard treatment. Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment.
- Genetic: Protein expression analysis
- Genetic: Proteomic profiling
- Other: Laboratory biomarker analysis
- Changes in serum and urine proteomic profiles [ Time Frame: Ongoing until patient progression ]
- Prognostic and biochemical markers of early disease progression [ Time Frame: Ongoing until patient progression ]
- Protein expression and temporal alterations [ Time Frame: Ongoing until patient progression ]
- Molecular targets [ Time Frame: Ongoing until patient progression ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955435
|Dublin, Ireland, 18|
|Saint Luke's Radiation Oncology Network|
|Dublin, Ireland, 6|
|Principal Investigator:||John Gerard Armstrong, MD, MB, MRCPI||Saint Luke's Hospital|