Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer
- Detect changes in serum and urine proteomic profiles that predict outcome in patients
with newly diagnosed localized prostate cancer treated with hormonal therapy and
- 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
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.
Observational Model: Cohort, Time Perspective: Prospective
Changes in serum and urine proteomic profiles
Ongoing until patient progression
John Gerard Armstrong, MD, MB, MRCPI
Saint Luke's Hospital
Ireland: Health Information and Quality Authority