Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT00955435
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2009-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15
Sponsor:
Cancer Trials Ireland
Organization:
Study Overview
Official Title:
Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
OBJECTIVES:
* 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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: