An observational study in Prostate Cancer, sponsored by Cancer Trials Ireland. Status unknown at 2 sites in Ireland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Cancer Trials Ireland · Observational
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.
OBJECTIVES:
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 60 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Cancer Trials Ireland is the lead sponsor of 69 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with localised prostate cancer who will receive radiation therapy plus hormonal therapy, for 4 - 8 months, are eligible for the trial. Patients will be eligible to participate in the trial provided they have not received prior therapy for their prostate cancer. It is planned that 60 patients will participate in the research study. All patients will receive approx 4 months of induction hormone therapy (LHRH agonist and Bicalutamide) prior to starting radiotherapy treatment.
Exclusion criteria:
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.
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
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Cancer Trials Ireland